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GLP-1 and peptides, explained plainly.

What each one is, whether the FDA has approved it, and what is known about its risks. We do not give doses and we do not tell you what to take. Your clinician decides.

FDA approved medicines

Approved for specific uses. Always indication specific.

FDA approved: indication specific

Semaglutide

Also known as Ozempic, Rybelsus, Wegovy
What it is

GLP-1 receptor agonist; approved products cover type 2 diabetes, chronic weight management and selected cardiovascular-risk indications.

What it can do

Can lower HbA1c, body weight and appetite; benefits depend on the labeled product and population.

Known risks

Nausea, vomiting, diarrhea/constipation, dehydration; gallbladder disease, pancreatitis, kidney injury during dehydration and diabetic-retinopathy complications. Thyroid C-cell tumor boxed warning/contraindication applies to relevant products.

FDA approved: indication specific

Tirzepatide

Also known as Mounjaro, Zepbound
What it is

Dual GIP/GLP-1 receptor agonist; approved products cover type 2 diabetes, chronic weight management and obesity-related obstructive sleep apnea.

What it can do

Can lower HbA1c, body weight and appetite; may improve OSA severity when weight loss occurs in the labeled population.

Known risks

GI effects, dehydration, gallbladder disease, pancreatitis; hypoglycemia with insulin/secretagogues, kidney injury during dehydration, hair loss in some weight-loss patients. Thyroid C-cell tumor boxed warning/contraindication.

FDA approved: indication specific

Liraglutide

Also known as Victoza, Saxenda, Xultophy
What it is

Daily GLP-1 receptor agonist for type 2 diabetes or chronic weight management, depending on product.

What it can do

Can improve glycemia, weight and appetite; cardiovascular benefit is labeled for selected diabetes patients.

Known risks

GI effects, gallbladder disease, pancreatitis, dehydration/kidney injury, increased heart rate and injection reactions; thyroid C-cell tumor boxed warning/contraindication.

FDA approved: type 2 diabetes

Dulaglutide, exenatide and lixisenatide

Also known as Trulicity, Byetta, Soliqua
What it is

Earlier GLP-1 receptor agonists used for glucose control; product-specific cardiovascular and renal labeling differs.

What it can do

Lower glucose and often modestly reduce weight/appetite.

Known risks

GI effects; hypoglycemia with insulin/secretagogues; pancreatitis, gallbladder and renal concerns vary by product. Thyroid C-cell tumor warning applies to dulaglutide, not uniformly to the whole group.

FDA approved: chronic weight management (2026)

Orforglipron

Also known as Foundayo
What it is

GLP-1 receptor agonist tablet, approved in 2026 together with a reduced-calorie diet and more physical activity to reduce excess body weight and keep it off long term in adults with obesity, or with overweight and at least one weight-related condition.

What it can do

Reduces body weight and food intake, likely through less appetite; approved only for the adults named in its indication.

Known risks

Most common: nausea, constipation, diarrhea, vomiting, indigestion, abdominal pain and headache. Warnings include acute pancreatitis, severe GI reactions, kidney injury from dehydration, hypoglycemia with insulin or sulfonylureas, hypersensitivity, gallbladder disease, diabetic-retinopathy complications in type 2 diabetes and aspiration during anesthesia or deep sedation. Thyroid C-cell tumor boxed warning; contraindicated with a personal or family history of medullary thyroid carcinoma or MEN 2.

FDA approved: product specific

Insulin products, including insulin icodec-abae

Also known as Awiqli
What it is

Peptide hormone replacement for diabetes. Once-weekly insulin icodec-abae was approved in 2026 for adults with type 2 diabetes.

What it can do

Essential glucose control; prevents acute and chronic complications when correctly matched to need.

Known risks

Hypoglycemia, weight gain, injection-site/lipodystrophy changes, edema and hypokalemia; errors can be life-threatening.

FDA approved: diabetes adjunct

Pramlintide

Also known as SymlinPen
What it is

Amylin analogue used with mealtime insulin in selected patients.

What it can do

Can reduce post-meal glucose excursions and appetite.

Known risks

Severe hypoglycemia risk with insulin, nausea, reduced appetite and dosing complexity.

FDA approved: severe hypoglycemia rescue

Glucagon and dasiglucagon

Also known as Baqsimi, Gvoke, Zegalogue
What it is

Raises blood glucose in severe hypoglycemia; some glucagon products also have diagnostic uses.

What it can do

Rapid rescue when a person cannot safely take oral carbohydrate.

Known risks

Nausea/vomiting, headache, hypersensitivity; recurrent hypoglycemia if underlying cause is not corrected.

FDA approved: rare genetic obesity

Setmelanotide

Also known as Imcivree
What it is

Melanocortin-4 receptor agonist for specific genetically confirmed obesity syndromes.

What it can do

Can reduce hunger and weight in eligible genetic conditions.

Known risks

Skin darkening, injection reactions, nausea/vomiting, headache, spontaneous sexual reactions; depression and suicidal ideation require active monitoring.

FDA approved: generalized lipodystrophy

Metreleptin

Also known as Myalept
What it is

Leptin analogue used with diet in congenital or acquired generalized lipodystrophy.

What it can do

Can improve severe metabolic abnormalities caused by leptin deficiency.

Known risks

Antidrug antibodies with loss of efficacy/infection risk, lymphoma warning, hypoglycemia with diabetes drugs and hypersensitivity; restricted program.

FDA approved: hiv lipodystrophy

Tesamorelin

Also known as Egrifta SV/WV
What it is

Growth-hormone-releasing-factor analogue for reducing excess abdominal fat in adults with HIV lipodystrophy; not a general weight-loss drug.

What it can do

Can reduce visceral abdominal adipose tissue in the labeled population.

Known risks

Raised IGF-1, edema, joint/muscle symptoms, carpal-tunnel symptoms, glucose intolerance and hypersensitivity; avoid active malignancy and pregnancy.

FDA approved: growth hormone deficiency/selected disorders

Somatropin, lonapegsomatropin and somapacitan

Also known as Skytrofa, Sogroya, Ngenla
What it is

Growth-hormone products; exact age groups and indications vary by product.

What it can do

Can normalize growth or improve body composition/function in correctly diagnosed deficiency.

Known risks

Edema, joint/muscle pain, carpal tunnel, glucose intolerance, intracranial hypertension and possible worsening of sleep apnea; avoid active malignancy.

FDA approved: severe primary igf-1 deficiency

Mecasermin

Also known as Increlex
What it is

Recombinant IGF-1 for selected children with severe primary deficiency.

What it can do

Can improve linear growth in eligible patients.

Known risks

Hypoglycemia, intracranial hypertension, enlarged tonsils/adenoids, ear problems and injection reactions; malignant-neoplasia warning.

FDA approved: osteoporosis

Teriparatide and abaloparatide

Also known as Forteo, Bonsity, Tymlos
What it is

PTH-receptor peptide medicines that stimulate bone formation in high-risk osteoporosis.

What it can do

Increase bone density and reduce fracture risk in selected patients.

Known risks

Dizziness/orthostatic symptoms, nausea, headache, hypercalcemia or hypercalciuria; treatment duration and osteosarcoma risk factors require clinical review.

FDA approved: hypoparathyroidism

Palopegteriparatide

Also known as Yorvipath
What it is

Long-acting PTH replacement for adults with hypoparathyroidism.

What it can do

Can improve calcium control and reduce reliance on conventional therapy in appropriate patients.

Known risks

Low or high calcium, headache, diarrhea, nausea, injection reactions and urinary-calcium changes.

FDA approved: limited bone/paget indications

Calcitonin-salmon

Also known as Miacalcin, Fortical
What it is

Peptide hormone analogue; labeling depends on nasal or injectable product.

What it can do

May reduce bone resorption or help selected Paget/hypercalcemia patients.

Known risks

Nasal irritation, nausea/flushing and hypersensitivity; long-term use has a malignancy signal and a limited modern role.

FDA approved: endocrine/neuroendocrine disorders

Octreotide, lanreotide and pasireotide

Also known as Sandostatin, Somatuline, Signifor
What it is

Somatostatin analogues for acromegaly and selected neuroendocrine or Cushing-related indications.

What it can do

Can suppress hormone excess and control symptoms/tumor-related secretion.

Known risks

GI symptoms, gallstones, glucose abnormalities, slow heart rate and thyroid effects; pasireotide often causes hyperglycemia and can affect QT/liver tests.

FDA approved: short bowel syndrome

Teduglutide

Also known as Gattex
What it is

GLP-2 analogue for patients dependent on parenteral support.

What it can do

Can increase intestinal absorption and reduce parenteral-support needs.

Known risks

Abdominal pain/distension, obstruction, fluid overload, biliary/pancreatic disease and possible growth of GI neoplasia.

FDA approved: constipation/ibs-c

Linaclotide and plecanatide

Also known as Linzess, Trulance
What it is

Guanylate-cyclase-C peptide agonists acting in the intestine.

What it can do

Can improve constipation and abdominal symptoms.

Known risks

Diarrhea and dehydration; boxed contraindication/warning for very young children varies by label.

FDA approved: product specific

Desmopressin

Also known as DDAVP, Nocdurna
What it is

Vasopressin analogue for central diabetes insipidus, nocturia/bedwetting or hemostatic indications depending on formulation.

What it can do

Reduces excessive urine output or raises selected clotting factors.

Known risks

Hyponatremia/water intoxication can cause seizures or death; headache and nasal/local effects. Fluid restriction and formulation-specific rules matter.

FDA approved: obstetric use

Oxytocin

Also known as Pitocin
What it is

Peptide hormone used to induce/augment labor and control postpartum uterine bleeding.

What it can do

Effective uterine contraction under monitored obstetric care.

Known risks

Uterine hyperstimulation, fetal distress, rupture, hypotension/tachycardia and water intoxication; hospital-only monitoring.

FDA approved: product specific

GnRH agonists

Also known as Lupron, Zoladex, Supprelin, Synarel, Trelstar
What it is

Leuprolide, goserelin, histrelin, nafarelin and triptorelin suppress gonadal hormones after an initial stimulation phase.

What it can do

Useful in prostate cancer, endometriosis/fibroids, central precocious puberty and selected fertility protocols.

Known risks

Hot flashes, sexual dysfunction, mood/sleep changes, bone loss and metabolic/cardiovascular effects; temporary disease flare with some uses.

FDA approved: product specific

GnRH antagonists

Also known as Firmagon, Cetrotide, Ganirelix
What it is

Injectable degarelix for prostate cancer; cetrorelix and ganirelix for assisted reproduction.

What it can do

Rapid hormone suppression or prevention of premature ovulation.

Known risks

Injection reactions, hot flashes, sexual effects, liver/QT issues for degarelix; fertility protocols can have ovarian complications.

FDA approved: fertility/selected hypogonadism

hCG and gonadotropins (FSH/hMG)

Also known as Pregnyl, Novarel, Ovidrel, Follistim, Gonal-f, Menopur
What it is

Glycoprotein hormones used for ovulation induction/assisted reproduction and selected male hypogonadotropic hypogonadism. hCG is not approved for weight loss.

What it can do

Can induce follicular development/ovulation or support testosterone production and spermatogenesis when appropriately indicated.

Known risks

Ovarian hyperstimulation, multiple gestation and thrombosis; in males, gynecomastia, edema and injection reactions.

FDA approved: acquired generalized hsdd

Bremelanotide

Also known as Vyleesi
What it is

Melanocortin receptor agonist approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder; not approved for men or erectile dysfunction.

What it can do

Can improve sexual desire/distress for some eligible patients.

Known risks

Very common nausea; transient blood-pressure rise with heart-rate reduction, flushing/headache and focal hyperpigmentation. Avoid uncontrolled hypertension or known cardiovascular disease.

FDA approved: erythropoietic protoporphyria

Afamelanotide

Also known as Scenesse
What it is

Melanocortin analogue implant that increases pain-free light exposure in adults with EPP.

What it can do

Can reduce phototoxicity burden and support outdoor function.

Known risks

Implant-site reactions, nausea/headache and increased pigmentation/moles; requires skin surveillance.

FDA approved: rett syndrome

Trofinetide

Also known as Daybue
What it is

IGF-1-derived peptide analogue for Rett syndrome in patients two years and older.

What it can do

Can improve selected Rett syndrome symptoms.

Known risks

Diarrhea, vomiting and weight loss can be substantial.

FDA approved: achondroplasia

Vosoritide and navepegritide

Also known as Voxzogo, Yuviwel
What it is

CNP-pathway peptide therapies for increasing linear growth in children with achondroplasia and open growth plates; age criteria differ.

What it can do

Can increase annualized growth velocity.

Known risks

Injection reactions, vomiting, dizziness or transient low blood pressure; long-term functional benefit needs follow-up.

FDA approved: barth syndrome (2025)

Elamipretide

Also known as Forzinity
What it is

Mitochondria-targeting peptide approved to improve muscle strength in patients with Barth syndrome weighing at least 30 kg.

What it can do

May improve disease-specific muscle strength in the labeled group.

Known risks

Injection-site reactions are prominent; hypersensitivity and disease-specific uncertainty require specialist follow-up.

FDA approved: chronic hepatitis d (2026)

Bulevirtide-gmod

Also known as Hepcludex
What it is

Viral-entry inhibitor peptide for adults with chronic HDV without cirrhosis or with compensated cirrhosis; accelerated approval.

What it can do

Can reduce HDV RNA and normalize ALT; clinical-outcome benefit still requires confirmation.

Known risks

Injection reactions, headache, abdominal pain, fatigue, pruritus and hypersensitivity; stopping can trigger severe acute HDV/HBV exacerbation.

FDA approved: polycythemia vera (2026)

Rusfertide

Also known as Mimrylo
What it is

Hepcidin-mimetic peptide for erythrocytosis in adults with polycythemia vera.

What it can do

Can maintain hematocrit control and reduce phlebotomy burden in eligible patients.

Known risks

Injection reactions and iron-restriction effects; excessive response may contribute to anemia/iron changes. Very recent approval means post-market experience is limited.

FDA approved: plaque psoriasis (2026)

Icotrokinra

Also known as Icotyde
What it is

Oral targeted peptide that blocks the IL-23 receptor for moderate-to-severe plaque psoriasis in eligible adults and adolescents.

What it can do

Can improve skin disease without injection.

Known risks

Immune/infection and product-specific adverse effects require current-label review; post-market experience is limited because approval is recent.

FDA approved, specialist care

Approved and used in specialist settings. The care team leads.

FDA approved: severe chronic pain

Ziconotide

Also known as Prialt
What it is

Intrathecal peptide analgesic for severe chronic pain in selected patients.

What it can do

Non-opioid analgesia when other therapies are inadequate.

Known risks

Severe neuropsychiatric/cognitive effects, dizziness, ataxia and infection risk; contraindicated with history of psychosis.

FDA approved: hereditary angioedema attacks

Icatibant and ecallantide

Also known as Firazyr, Kalbitor
What it is

Peptide-pathway treatments for acute hereditary angioedema attacks.

What it can do

Can shorten attacks when used promptly.

Known risks

Injection reactions; ecallantide can cause anaphylaxis and requires supervised administration.

FDA approved: procedural anticoagulation/antiplatelet care

Bivalirudin and eptifibatide

Also known as Angiomax, Integrilin
What it is

Short peptide medicines used around acute coronary or catheter procedures.

What it can do

Reduce procedure-related thrombosis in labeled settings.

Known risks

Bleeding and thrombocytopenia; dosing depends on renal/clinical factors.

FDA approved: hiv

Enfuvirtide

Also known as Fuzeon
What it is

HIV fusion-inhibitor peptide used with other antiretroviral drugs in treatment-experienced patients.

What it can do

Can suppress resistant HIV as part of an effective regimen.

Known risks

Frequent injection-site reactions, hypersensitivity and pneumonia signal.

FDA approved: secondary hyperparathyroidism

Etelcalcetide

Also known as Parsabiv
What it is

Peptide calcimimetic given during hemodialysis.

What it can do

Lowers parathyroid hormone in dialysis patients.

Known risks

Hypocalcemia, QT-related risk, nausea/vomiting and heart-failure concerns.

FDA approved: complement-mediated diseases

Pegcetacoplan and zilucoplan

Also known as Empaveli, Syfovre, Zilbrysq
What it is

Peptide-based complement inhibitors; indications include PNH/GA for pegcetacoplan products and generalized myasthenia gravis for zilucoplan.

What it can do

Can reduce complement-mediated tissue damage in specific diseases.

Known risks

Serious infection risk, especially encapsulated bacteria; injection reactions and product-specific ocular/systemic risks. Vaccination/risk plans are essential.

FDA approved: stem-cell mobilization

Motixafortide

Also known as Aphexda
What it is

Cyclic-peptide CXCR4 inhibitor used with filgrastim to mobilize stem cells for autologous transplant in multiple myeloma.

What it can do

Improves collection of mobilized stem cells.

Known risks

Injection reactions, hypersensitivity, leukocytosis and procedure-related risks.

FDA approved: relapsing multiple sclerosis

Glatiramer acetate

Also known as Copaxone, Glatopa
What it is

Synthetic polypeptide mixture used as disease-modifying therapy.

What it can do

Reduces relapse activity in labeled MS populations.

Known risks

Injection reactions, lipoatrophy and immediate post-injection chest pain/flushing/dyspnea; rare serious hypersensitivity.

FDA approved: immune thrombocytopenia/selected radiation injury

Romiplostim

Also known as Nplate
What it is

Thrombopoietin-receptor peptibody that raises platelet production.

What it can do

Can reduce bleeding risk in chronic ITP when indicated.

Known risks

Excess platelets/thrombosis, marrow reticulin changes and rebound thrombocytopenia; headache/joint symptoms.

FDA approved: imaging/therapy

Radiolabeled somatostatin analogues

Also known as Netspot, Lutathera
What it is

Gallium Ga-68 dotatate imaging and lutetium Lu-177 dotatate therapy target somatostatin receptors in neuroendocrine tumors.

What it can do

Enable tumor imaging or receptor-targeted radiotherapy.

Known risks

Radiation exposure; Lu-177 therapy can cause nausea, marrow suppression, renal/liver toxicity and secondary malignancy risk.

FDA approved: diagnostic use

Secretin, sincalide and cosyntropin

Also known as ChiRhoStim, Kinevac, Cortrosyn
What it is

Short peptide hormones/analogues used in pancreatic/biliary imaging or adrenal-function testing.

What it can do

Support diagnosis under controlled clinical conditions.

Known risks

Transient GI, flushing, BP/HR or hypersensitivity effects; false interpretation if protocol is wrong.

FDA approved: critical care

Vasopressin, terlipressin and angiotensin II

Also known as Vasostrict, Terlivaz, Giapreza
What it is

Peptide vasoactive drugs used for shock, vasodilatory states or hepatorenal syndrome in monitored settings.

What it can do

Can raise perfusion pressure or improve kidney outcomes in selected critical illness.

Known risks

Ischemia, arrhythmia, respiratory failure or fluid/electrolyte complications; risks are indication- and product-specific.

FDA approved: diagnostic use

Macimorelin

Also known as Macrilen
What it is

Oral growth hormone secretagogue receptor agonist approved only for testing whether an adult has growth hormone deficiency; it is a diagnostic test, not a treatment.

What it can do

Supports the diagnosis of adult growth hormone deficiency under clinical supervision.

Known risks

Most common: altered taste, dizziness, headache, fatigue, nausea, hunger, diarrhea and a slow heart rate. It can prolong the QT interval; certain other medicines can make the test result wrong.

FDA approved: ckd-associated pruritus (hemodialysis)

Difelikefalin

Also known as Korsuva
What it is

Kappa opioid receptor agonist peptide given by the dialysis team, approved for moderate-to-severe itching caused by chronic kidney disease in adults on hemodialysis.

What it can do

Can reduce itching in the adults on hemodialysis it is approved for.

Known risks

Most common: diarrhea, dizziness, nausea, gait problems including falls, high potassium, headache, sleepiness and changes in mental state; it may impair driving. Not studied in peritoneal dialysis.

FDA approved: product specific

Corticotropin (repository corticotropin injection)

Also known as Acthar Gel, Purified Cortrophin Gel
What it is

Long-acting pituitary hormone (ACTH) peptide gel that makes the adrenal glands release cortisol and related hormones; approved for specialist uses such as infantile spasms (Acthar Gel), flares of multiple sclerosis and certain inflammatory diseases, depending on the product.

What it can do

Can calm certain inflammatory flares in the specialist uses it is approved for; the specialist decides.

Known risks

Warnings include infections, Cushing’s syndrome and adrenal insufficiency when it is stopped, high blood pressure, salt and water retention and low potassium, gastrointestinal perforation and bleeding, mood and behavior changes, eye effects, hypersensitivity, slowed growth in children and lower bone density. In infants with infantile spasms the most common reactions are infections, convulsions, high blood pressure, irritability and fever.

In development, not approved

Not FDA approved. We explain what is known and never recommend them.

Under FDA review for weight management: not approved

CagriSema (cagrilintide + semaglutide)

What it is

Fixed-dose amylin/GLP-1 combination. Submitted to FDA in December 2025 for chronic weight management; type 2 diabetes development continues.

Known risks

Most reported events are GI and generally consistent with incretin/amylin therapy; final contraindications, warnings and quality controls are not established until approval.

Phase 3 investigational: not FDA approved

Retatrutide

What it is

Single-molecule GIP/GLP-1/glucagon triple receptor agonist studied for obesity, diabetes and related complications. “GLP-3” is not a scientific drug class.

Known risks

GI effects and potential heart-rate, gallbladder, pancreatic, hydration and metabolic risks require trial-grade monitoring; long-term and post-market safety is unknown.

Phase 3 investigational: not FDA approved

Survodutide

What it is

Dual glucagon/GLP-1 receptor agonist studied for obesity and MASH/liver disease.

Known risks

GI intolerance and possible gallbladder, pancreatic, heart-rate and liver-related issues; final safety profile is not established.

Investigational in the us: not FDA approved

Mazdutide

What it is

Dual GLP-1/glucagon receptor agonist studied for obesity and metabolic disease; approvals in other countries do not equal FDA approval.

Known risks

GI and class-related metabolic, gallbladder, pancreatic and heart-rate risks; US labeling and quality assurance do not exist.

Late-stage investigational: not FDA approved

Pemvidutide

What it is

GLP-1/glucagon dual agonist studied for obesity and metabolic liver disease.

Known risks

GI effects and possible heart-rate, gallbladder, pancreatic and hepatic risks; long-term safety and final benefit-risk are unknown.

Investigational: not FDA approved

Cagrilintide alone and other next-generation amylin/incretin peptides

What it is

Amylin or multi-receptor candidates being studied for obesity/diabetes; development stage differs by molecule.

Known risks

GI intolerance, dehydration and hypoglycemia when combined with glucose-lowering drugs are plausible; molecule-specific long-term safety is unknown.

Investigational: not FDA approved

Tesofensine

What it is

Small-molecule triple reuptake inhibitor (research code NS 2330) that has been studied for weight reduction in obesity and earlier in Parkinson’s and Alzheimer’s disease. There is no FDA-approved product, and products sold today are not an approved medicine.

Known risks

Studies looked at its effect on heart rate, also together with metoprolol; content and purity of the products sold today are unknown. Heart rate, blood pressure, sleep and mood changes belong with the care team.

Sold outside approved channels

Not FDA approved. We explain what is known and never recommend them.

Unapproved; reviewed by FDA pcac in 2026

BPC-157 (free base/acetate)

What it is

Marketed for gut, tendon or wound healing. FDA evaluated ulcerative-colitis claims; there is no FDA-approved BPC-157 product.

Known risks

Unknown human safety, immunogenicity and impurity/aggregation risk. FDA staff found insufficient characterization, safety and efficacy support; adverse reports do not prove causality.

Unapproved; reviewed by FDA pcac in 2026

TB-500 / thymosin-beta-4 fragments

What it is

Marketed for wound or musculoskeletal healing. TB-500 products may not be chemically identical to full thymosin beta-4.

Known risks

FDA identified absence of human clinical exposure data for the nominated substances and potential injectable immunogenicity/quality risks.

Unapproved; reviewed by FDA pcac in 2026

KPV

What it is

Alpha-MSH-derived tripeptide marketed for inflammation, gut or skin conditions.

Known risks

FDA staff found no human PK/PD, exposure or clinical studies; safety and immunogenicity are unknown.

Unapproved; reviewed by FDA pcac in 2026

MOTS-c

What it is

Mitochondrial-derived peptide marketed for metabolism, exercise, obesity or longevity.

Known risks

FDA staff found no human clinical exposure studies for the nominated substances; systemic and long-term risks are unknown.

Unapproved; reviewed by FDA pcac in 2026

Semax

What it is

ACTH-derived peptide marketed for cognition, migraine or neuroprotection.

Known risks

Unknown product quality and long-term safety; FDA staff noted possible antithrombotic properties as a bleeding concern and limited human PK data.

Unapproved

Selank

What it is

Peptide marketed for anxiety, cognition or stress; no FDA-approved product.

Known risks

Human evidence, interactions, dosing reliability and long-term safety are insufficient; compounded/online quality is uncertain.

Unapproved; reviewed by FDA pcac in 2026

Epitalon

What it is

Tetrapeptide marketed for sleep, aging or “telomere” effects.

Known risks

FDA staff found no adequate human PK or clinical safety evidence; cancer, endocrine and long-term risks are unknown.

Unapproved; reviewed by FDA pcac in 2026

Emideltide / DSIP

What it is

“Delta sleep-inducing peptide” marketed for sleep or withdrawal.

Known risks

Reported transient headache, nausea and vertigo; hypotension occurred in older IV research. Subcutaneous safety is not established.

503a category 1 for non-injectable routes: not FDA approved

GHK-Cu

What it is

Copper-binding tripeptide marketed for skin/hair or wound care. FDA’s Category 1 entry applies only to non-injectable routes and means “under evaluation,” not approval.

Known risks

Irritation, allergy and uncertain absorption/quality; injectable use is outside the Category 1 entry and has additional infection/immunogenicity risk.

Unapproved

CJC-1295 (with or without DAC)

What it is

Long-acting GHRH analogue marketed to raise growth hormone/IGF-1; chemical versions differ.

Known risks

Edema, joint/carpal-tunnel symptoms, glucose intolerance, headache, possible intracranial hypertension and theoretical tumor-growth risk; product purity is uncertain.

503b category 2: may present significant safety risks; unapproved

Ipamorelin

What it is

Growth-hormone secretagogue peptide marketed for recovery, sleep or body composition.

Known risks

Unknown long-term safety/quality; possible edema, headache, glucose effects, increased appetite and GH/IGF-1-related risks.

503b category 2: may present significant safety risks; unapproved (ghrp-2: injectable and nasal routes)

GHRP-2 and GHRP-6

What it is

GH secretagogue peptides marketed for growth, appetite, recovery or body composition.

Known risks

Insufficient nomination support; possible glucose, appetite, edema and endocrine effects plus injectable quality/immunogenicity risks.

No current FDA-approved product; historical products discontinued

Sermorelin

What it is

GHRH analogue marketed by peptide clinics for GH deficiency, sleep or anti-aging.

Known risks

GH/IGF-1-related risks, injection reactions and uncertain compounded quality; “formerly approved” is not the same as a currently approved product.

No current FDA-approved product; historical products discontinued

Gonadorelin

What it is

Synthetic gonadotropin-releasing hormone (GnRH) peptide; the human products once approved by the FDA are discontinued, and products sold today are not an approved medicine.

Known risks

Content, purity and long-term safety of the products sold today are unknown; effects on reproductive hormones, injection reactions and hypersensitivity belong with the care team.

Unapproved

Hexarelin

What it is

Synthetic growth hormone–releasing peptide (research code EP-23905; FDA substance name examorelin). There is no FDA-approved product, and products sold today are not an approved medicine.

Known risks

Content, purity and long-term safety of the products sold today are unknown; effects on hormones and blood sugar, injection reactions and hypersensitivity belong with the care team.

503a category 1: under evaluation; not FDA approved

NAD+ (injection or IV infusion)

What it is

Nicotinamide adenine dinucleotide (NAD, coenzyme I), a coenzyme found widely in nature that carries electrons in many enzyme reactions; given from compounding pharmacies or clinics as an injection or IV infusion, not as an FDA-approved product. Not the same as oral NAD+ precursor supplements.

Known risks

Injection and infusion reactions, sterility and quality of compounded products; any new symptom during or after an infusion belongs with the care team.

Unapproved

AOD-9604 / hGH fragment 176–191

What it is

Growth-hormone fragment marketed for fat loss.

Known risks

Human long-term safety, endocrine effects, impurities and dosing reliability are uncertain.

Unapproved

IGF-1 LR3

What it is

Long-acting IGF-1 analogue marketed for muscle growth or recovery; distinct from FDA-approved mecasermin.

Known risks

Potential severe hypoglycemia, edema, organ/tissue growth and tumor-related risk; product purity and potency are unknown.

503a category 3 for mgf; unapproved

MGF / PEG-MGF

What it is

IGF-1 splice-product fragments marketed for muscle/tendon repair.

Known risks

Unknown systemic, growth-promoting, glucose, immunogenicity and impurity risks.

Unapproved in the united states

Thymosin alpha-1 / thymalfasin

What it is

Immune-modulating peptide approved in some countries and marketed for infection, cancer support or “immune optimization.”

Known risks

Fever/flu-like symptoms, immune effects, interactions and injectable quality risk; long-term safety for wellness use is unclear.

503a category 2: significant safety concerns; unapproved

Kisspeptin-10

What it is

Reproductive-neuroendocrine peptide marketed for fertility, testosterone or libido.

Known risks

FDA identified significant safety concerns for compounding; endocrine overstimulation, pregnancy/fertility consequences and unknown product quality are concerns.

503a and 503b category 2: may present significant safety risks; unapproved: not a peptide

Ibutamoren (MK-677)

What it is

Oral ghrelin-receptor agonist often sold as a “peptide” for GH release, sleep or muscle gain.

Known risks

FDA identified significant safety concerns; appetite/weight gain, edema, glucose intolerance and other GH/IGF-1-related risks are concerns.

503a category 1: under evaluation; not FDA approved

Vasoactive intestinal peptide / aviptadil

What it is

Neuropeptide marketed or studied for pulmonary/inflammatory uses.

Known risks

Low blood pressure, flushing, diarrhea, tachycardia and unknown inhaled/injectable quality or immunogenicity.

503a category 3: unapproved

Cibinetide / ARA-290

What it is

Erythropoietin-derived tissue-protective peptide studied for neuropathy/inflammation.

Known risks

Insufficient information for FDA to evaluate the compounding nomination; long-term, immune and product-quality risks are unknown.

503a category 3: unapproved

Thymulin acetate

What it is

Thymic peptide marketed for immune or inflammatory conditions.

Known risks

Insufficient supporting information; endocrine/immune, infection and injectable quality risks are unknown.

Unapproved

LL-37

What it is

Antimicrobial host-defense peptide marketed for infection, immunity or wound healing.

Known risks

Can be pro-inflammatory/cytotoxic; systemic effects, immune reactions, impurities and dosing are not established.

Unapproved

Melanotan II

What it is

Melanocortin analogue sold for tanning or sexual effects; not the same as approved afamelanotide or bremelanotide products.

Known risks

Nausea, flushing, spontaneous erections/priapism, BP/HR effects and darkening/changing moles; counterfeit/impurity risk.

Unapproved

Follistatin products / gene-peptide mixtures

What it is

Marketed to inhibit myostatin and increase muscle.

Known risks

Unknown potency, immune/tumor/reproductive effects and irreversible risks for gene-based products; contamination risk.

Experimental / unapproved

PNC-27, humanin and FOXO4-DRI

What it is

Research peptides marketed online for cancer killing, mitochondrial health or senolysis/longevity.

Known risks

Human dose, distribution, interactions, immune effects, cancer risk and manufacturing quality are unknown.

503a category 1: under evaluation; not blanket FDA approval

Glutathione (tripeptide), compounded routes

What it is

Antioxidant tripeptide marketed for wellness, skin lightening or respiratory uses; approved-drug status and compounding status depend on product/route.

Known risks

Route-specific allergy, bronchospasm, infection/contamination and impurity risks; IV/inhaled use needs medical oversight.

Unapproved: on the FDA list of bulk drug substances that may present significant safety risks

Dihexa

What it is

Warning-only entry. No FDA-approved product; listed by FDA as “Dihexa acetate” among bulk drug substances for compounding that may present significant safety risks. Kept in the catalog only so that a patient can name it and Aiden can track it neutrally with its source.

Known risks

FDA has not identified any human exposure data on drug products containing dihexa acetate administered via any route of administration, and lacks important information regarding any safety issues, including whether it would cause harm if administered to humans. Product purity and quality are unknown.

Unapproved: sarm; cannot be legally marketed as a dietary supplement or drug (FDA)

Ostarine / enobosarm (MK-2866)

What it is

Selective androgen receptor modulator (SARM), sold online as MK-2866 or enobosarm to build muscle mass and strength, often as a “dietary supplement” or “for research use only”. Ostarine has been authorized for investigation as a new drug, so FDA treats a product containing it as an unapproved new drug, not a dietary supplement.

Known risks

FDA: life-threatening reactions, including liver injuries that required hospitalization; SARMs also have the potential to cause increased risk of heart attack or stroke, psychosis/hallucinations, sleep disturbances, sexual dysfunction, liver injury and acute liver failure, infertility, pregnancy miscarriage and testicular shrinkage. Products are often sold without any warning; content and purity are unknown.

Unapproved: sarm; cannot be legally marketed as a dietary supplement or drug (FDA)

Ligandrol (LGD-4033)

What it is

Selective androgen receptor modulator (SARM), sold online as LGD-4033 to build muscle mass and strength, often as a “dietary supplement” or “for research use only”. FDA warning letters call products marketed this way unapproved new drugs.

Known risks

FDA: life-threatening reactions, including liver injuries that required hospitalization; SARMs also have the potential to cause increased risk of heart attack or stroke, psychosis/hallucinations, sleep disturbances, sexual dysfunction, liver injury and acute liver failure, infertility, pregnancy miscarriage and testicular shrinkage. Products are often sold without any warning; content and purity are unknown.

Unapproved: sarm; cannot be legally marketed as a dietary supplement or drug (FDA)

Testolone (RAD-140)

What it is

Selective androgen receptor modulator (SARM), sold online as RAD-140 to build muscle mass and strength, often as a “dietary supplement” or “for research use only”. FDA warning letters call products marketed this way unapproved new drugs.

Known risks

FDA: life-threatening reactions, including liver injuries that required hospitalization; SARMs also have the potential to cause increased risk of heart attack or stroke, psychosis/hallucinations, sleep disturbances, sexual dysfunction, liver injury and acute liver failure, infertility, pregnancy miscarriage and testicular shrinkage. Products are often sold without any warning; content and purity are unknown.

Unapproved: sarm; cannot be legally marketed as a dietary supplement or drug (FDA)

Andarine (S-4)

What it is

Selective androgen receptor modulator (SARM), sold online as S-4 to build muscle mass and strength, often as a “dietary supplement” or “for research use only”. FDA warning letters call products marketed this way unapproved new drugs; FDA also found andarine in a product labeled as a dietary supplement.

Known risks

FDA: life-threatening reactions, including liver injuries that required hospitalization; SARMs also have the potential to cause increased risk of heart attack or stroke, psychosis/hallucinations, sleep disturbances, sexual dysfunction, liver injury and acute liver failure, infertility, pregnancy miscarriage and testicular shrinkage. Products are often sold without any warning; content and purity are unknown.

Unapproved: sarm; cannot be legally marketed as a dietary supplement or drug (FDA)

YK-11

What it is

Substance sold online among SARMs (sellers also call it a “myostatin inhibitor”) to build muscle mass and strength, often as a “dietary supplement” or “for research use only”. FDA warning letters call products marketed this way unapproved new drugs.

Known risks

FDA: life-threatening reactions, including liver injuries that required hospitalization; SARMs also have the potential to cause increased risk of heart attack or stroke, psychosis/hallucinations, sleep disturbances, sexual dysfunction, liver injury and acute liver failure, infertility, pregnancy miscarriage and testicular shrinkage. Products are often sold without any warning; content and purity are unknown. FDA tested a bodybuilding product that listed YK-11 after a report of a stroke in a person who used it; the product also contained an undeclared anabolic steroid.

Unapproved new drug (FDA): not a sarm, sold with sarms

Cardarine (GW501516)

What it is

Not a SARM, but sold online with them as “Cardarine GW501516” for fat loss and energy, often “for research use only”. FDA warning letters list it among products marketed as SARMs and call them unapproved new drugs; no FDA-approved product contains it.

Known risks

No FDA-approved product and no FDA review of its safety. FDA lists it among products marketed as SARMs, about which FDA has safety concerns: life-threatening reactions, including liver toxicity, and a potential increased risk of heart attack and stroke. Product content and purity are unknown.

Sex hormones

Not peptides. Talk with your clinician about symptoms and labs.

FDA-approved products: steroid hormone, not a peptide

Testosterone

What it is

Approved formulations treat male hypogonadism under product labeling. FDA requested further label updates in June 2026; use in women/gender-affirming care is not an FDA-labeled indication for testosterone products.

What it can do

Can improve sexual symptoms, anemia, bone/muscle outcomes or wellbeing in correctly diagnosed deficiency; benefit varies by patient and endpoint.

Known risks

Raises blood pressure class-wide; erythrocytosis, acne, edema, infertility/testicular atrophy, sleep-apnea worsening and prostate/BPH issues. Gel transfer and formulation-specific risks matter.

FDA-approved products: steroid hormone, not a peptide

Estradiol / estrogen therapy

What it is

Product-specific uses include menopausal vasomotor/genitourinary symptoms, hypoestrogenism and selected osteoporosis prevention. Gender-affirming use is generally off-label in the US.

What it can do

Often highly effective for hot flashes/night sweats and genitourinary symptoms; may protect bone in appropriate patients.

Known risks

Route/patient-specific risks include venous thromboembolism, stroke, gallbladder disease and breast/endometrial effects. Unopposed systemic estrogen raises endometrial-cancer risk when a uterus is present.

FDA-approved products: steroid hormones, not peptides

Progesterone / progestogens

Also known as Prometrium
What it is

Used for endometrial protection with estrogen, secondary amenorrhea, contraception or fertility support depending on product.

What it can do

Protects the endometrium when required and can support reproductive indications.

Known risks

Sedation/dizziness, mood change, headache, breast symptoms and irregular bleeding; thrombosis/breast-risk profile depends on molecule and regimen.

FDA approved: steroid, not a peptide

Prasterone (DHEA), vaginal

Also known as Intrarosa
What it is

Vaginal prasterone is approved for moderate-to-severe pain with sex due to vulvar/vaginal atrophy after menopause. Systemic DHEA wellness use is not the same approval.

What it can do

Can improve local genitourinary symptoms and dyspareunia.

Known risks

Vaginal discharge and abnormal cervical smear findings; unexplained bleeding or hormone-sensitive cancer history needs clinical review.

FDA approved for ovulatory dysfunction: not a peptide/hormone

Clomiphene citrate

Also known as Clomid
What it is

Selective estrogen-receptor modulator approved for ovulatory dysfunction in women. Use to raise testosterone in men is off-label.

What it can do

Can induce ovulation; may raise endogenous testosterone in some off-label male care.

Known risks

Visual symptoms, ovarian enlargement/multiple pregnancy, hot flashes, mood/headache and thrombotic risk; long-term male safety evidence is limited.

503a category 1: under evaluation; not FDA approved

Enclomiphene citrate

What it is

Clomiphene isomer marketed to raise endogenous testosterone while preserving fertility; not a peptide or hormone.

Known risks

Visual, mood, thrombotic and endocrine risks are incompletely defined; compounded quality and long-term outcomes are uncertain.

Not broadly FDA approved; steroids, not peptides

Pregnenolone and systemic DHEA products

What it is

Precursors marketed for energy, cognition, libido or “hormone balance.” FDA 503A Category 1 includes pregnenolone and 7-keto DHEA as substances under evaluation, not approvals.

Known risks

Acne/hair changes, mood/sleep effects, hormone-sensitive tissue effects and interactions; supplement/compounded content may vary.

How to read this

Facts, not advice.

The FDA status always comes first. Phase 3, compounding pharmacy or available online never means approved. These pages are general information and do not replace your care team. Source: Peptides, Related Hormones and Patient Signals, FDA status checked through 8 September 2026.

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