FDA-Approved Peptide Therapeutics

Weight management in adults and adolescents aged 12 or older with obesity, and adults with overweight plus a weight-related condition; cardiovascular risk reduction in adults with established cardiovascular disease and overweight or obesity; noncirrhotic MASH with F2–F3 fibrosis in adults. MASH approval is accelerated and depends on confirmatory clinical benefit. These are injection indications; other formulations have their own labels.

STEP weight-management trials and SELECT cardiovascular outcomes trial; the label also describes the MASH trial.

Boxed warning based on rodent thyroid C-cell tumors; human relevance is uncertain. Other warnings include pancreatitis, gallbladder disease and severe gastrointestinal reactions. Consult the full label for contraindications and monitoring.

Long-term weight management in adults with obesity or overweight plus a weight-related condition, and treatment of moderate-to-severe obstructive sleep apnea in adults with obesity, alongside diet and physical activity. Mounjaro is a separate product with separate indications.

Weight-management and obstructive sleep apnea trials described in sections 14.1 and 14.2 of the product label.

Boxed warning based on rodent thyroid C-cell tumors; human relevance is uncertain. Warnings include gastrointestinal reactions, pancreatitis and gallbladder disease. Delayed gastric emptying can affect oral medicines, including oral contraceptives.

Improvement of glycemic control in adults and children aged 10 or older with type 2 diabetes; cardiovascular event risk reduction in adults with type 2 diabetes and established cardiovascular disease. Saxenda is a separate weight-management product.

Glycemic-control trials and the LEADER cardiovascular trial described in the label.

Boxed warning based on rodent thyroid C-cell tumors; human relevance is uncertain. Other warnings include pancreatitis, gastrointestinal reactions and gallbladder disease.

Reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. It is not indicated for general weight loss; long-term cardiovascular safety is not established. WR and SV formulations are not substitutable.

Placebo-controlled studies of visceral adipose tissue reduction, summarized in section 14 of the label. The ingredient was initially approved in 2010; the WR formulation dates to 2025.

Contraindications include active malignancy and pregnancy. Warnings include elevated IGF-1, fluid retention, glucose intolerance and hypersensitivity.

Osteoporosis treatment in postmenopausal women at high fracture risk; increased bone mass in men with primary or hypogonadal osteoporosis at high risk; glucocorticoid-associated osteoporosis in men and women at high risk. Failed or intolerable alternative therapy is also addressed by the label.

Population-specific trials in section 14; fracture reduction in postmenopausal women should not be expanded into an identical fracture-outcome claim in men.

Warnings include hypersensitivity, osteosarcoma risk precautions, hypercalcemia and orthostatic hypotension. The current label retains osteosarcoma precautions even though the former boxed warning is absent.

Treatment of osteoporosis in postmenopausal women at high fracture risk, or after failure or intolerance of other therapy; treatment to increase bone density in men meeting the corresponding criteria. The male indication is an increase in bone density, not a demonstrated fracture-reduction claim.

The label describes the postmenopausal osteoporosis trial and the separate male bone-density study. Outcomes and populations should be interpreted separately.

Warnings include hypersensitivity, osteosarcoma risk precautions, orthostatic hypotension, hypercalcemia and urinary calcium/stone risks. The full label specifies patients in whom use should be avoided.

Reduction of GH and IGF-1 in selected acromegaly patients inadequately treated with other options; symptomatic control of severe carcinoid-associated diarrhea and flushing, and VIPoma-associated watery diarrhea. These are symptom-control indications, not a tumor-shrinkage claim.

Clinical studies in the injection label; long-acting products have separate formulation and dosing information.

Warnings include gallbladder abnormalities, glucose disturbances, cardiac effects and thyroid abnormalities.

Selected acromegaly patients; progression-free survival in adults with unresectable, well- or moderately differentiated, locally advanced or metastatic GEP-NETs; reduced short-acting rescue therapy in adults with carcinoid syndrome.

Separate acromegaly, neuroendocrine tumor and carcinoid-syndrome studies are summarized in the product label.

Warnings include gallstones, glucose disturbances, bradycardia, thyroid abnormalities and fat malabsorption.

Improved glycemic control in adults with type 2 diabetes, alongside diet and exercise. Extended-release exenatide products have separate labels; their indications and warnings should not be combined with Byetta.

Monotherapy and combination-treatment studies summarized in section 14 of the Byetta label.

Warnings include pancreatitis, hypoglycemia with certain other treatments, acute kidney injury associated with dehydration, gastrointestinal reactions and hypersensitivity. Byetta does not carry the extended-release product’s thyroid-tumor boxed warning.

Adjunctive treatment for type 1 or type 2 diabetes in patients using mealtime insulin who have not achieved desired glucose control despite optimal insulin therapy.

Separate type 1 and type 2 diabetes trials described in section 14; this is not a replacement for insulin.

Boxed warning for severe hypoglycemia when used with insulin. Patient selection, glucose monitoring and clinician-directed insulin adjustment are important.

Acquired, generalized HSDD in premenopausal women, with distress or interpersonal difficulty, when not attributable to another condition, relationship problems or a substance. Not indicated for men, postmenopausal women or sexual-performance enhancement.

Two placebo-controlled HSDD trials described in section 14 of the label.

Contraindicated in uncontrolled hypertension or known cardiovascular disease. Warnings include transient blood-pressure increases, focal hyperpigmentation and nausea.

Medically indicated induction or augmentation of labor and control of postpartum bleeding. Other obstetric uses and contraindications are specified in the label; it is not indicated for elective labor induction.

The label describes established obstetric use and required clinical monitoring. No particular pivotal phase III trial is asserted here.

Risks include excessive uterine contractions, fetal compromise and water intoxication. Clinical monitoring and careful administration are required.

Increased blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.

The product label describes the supporting pharmacology and clinical evidence; a particular trial should not be assumed to be the sole approval basis.

Warnings include worsening cardiac function and reversible diabetes insipidus after cessation. Reported adverse reactions include ischemia and electrolyte disturbances.

Treatment of severe hypoglycemia in adults and children aged 1 or older with diabetes. Injectable glucagon products have separate applications, administration instructions and indications.

Adult glucose-recovery comparisons and pediatric pharmacokinetic/safety data described in the label. The current age scope must not be inferred from older labels.

Contraindications include pheochromocytoma, insulinoma and hypersensitivity. Response can be limited when hepatic glycogen is depleted; nausea and vomiting may occur.