Category · 25 entries

Sexual & Reproductive Health

Melanocortin agonists, GnRH analogs, gonadotropins, and oxytocin-family peptides covering fertility, reproductive endocrinology, and sexual function.

FDA Approved

Afamelanotide

An FDA-approved selective MC1R agonist marketed as Scenesse — the first-in-class treatment for erythropoietic protoporphyria (EPP), delivered as a subdermal implant.

Not Approved (US)

Atosiban

Ferring's Tractocile — an oxytocin-receptor antagonist used in Europe and elsewhere as a tocolytic for short-term suppression of preterm labor between 24 and 33 weeks' gestation. Approved by the EMA in 2000; the FDA declined to approve atosiban in 1998 citing a higher fetal/infant death rate in the <26-week subgroup of the pivotal trial.

Not Approved (US)

Buserelin

A GnRH agonist widely used in Canada, the UK, Germany, and other markets (Suprecur, Suprefact) for prostate cancer, endometriosis, and IVF downregulation — but never FDA-approved in the United States.

Not Approved (US)

Carbetocin

Ferring's Pabal / Duratocin — a long-acting oxytocin analog used for prevention of postpartum hemorrhage after cesarean delivery. Approved in Canada, the UK, the EU, and (as heat-stable carbetocin) prequalified by WHO for low-resource settings. Not FDA-approved: the FDA declined to approve the product in 2006 and it has not been re-filed.

FDA Approved

Cetrorelix

Merck Serono's Cetrotide — a GnRH antagonist used during IVF controlled ovarian stimulation to block premature LH surges. Unlike GnRH agonists, produces immediate gonadotropin suppression without a flare, shortening IVF cycles.

Not Approved (US)

Corifollitropin alfa

Organon/Merck's Elonva — a recombinant long-acting FSH fusion protein (FSH-CTP) used as a single SC injection to replace the first week of daily FSH in IVF stimulation. Approved by the EMA in 2010; never approved in the United States.

FDA Approved

Degarelix

Ferring's Firmagon — a GnRH antagonist for advanced prostate cancer that achieves castrate testosterone within 3 days, eliminating the clinical flare risk of GnRH-agonist therapy in patients with symptomatic bone metastases or impending spinal cord compression.

FDA Approved

Follitropin alfa

EMD Serono's Gonal-f — the first recombinant human FSH approved by the FDA (1997). Used for ovulation induction, IVF controlled ovarian stimulation, and male hypogonadotropic hypogonadism fertility induction.

FDA Approved

Follitropin beta

Organon/Merck's Follistim AQ (Puregon internationally) — a recombinant human FSH produced independently of follitropin alfa but clinically equivalent; FDA-approved 1997 for ovulation induction and IVF controlled ovarian stimulation.

Not Approved (US)

Follitropin delta

Ferring's Rekovelle — a recombinant human FSH produced in a human cell line (PER.C6), dosed via a personalized algorithm based on serum AMH and body weight. Approved in the EU, UK, Canada, Australia, Japan, and China, but received an FDA Complete Response Letter in February 2026 over manufacturing issues; not currently approved in the United States.

FDA Approved

Ganirelix

Organon/Merck's Ganirelix Acetate (formerly Antagon; Orgalutran internationally) — a GnRH antagonist functionally equivalent to cetrorelix for IVF LH-surge prevention, dosed as a daily fixed 250 mcg SC injection.

Discontinued

Gonadorelin

The native GnRH decapeptide — the hypothalamic signal that drives LH/FSH release and downstream testosterone/estradiol production. Historically FDA-approved (Factrel, Lutrepulse), now widely used in TRT-adjacent fertility protocols as a testicular-preservation alternative to HCG.

FDA Approved

Goserelin

AstraZeneca's Zoladex — a long-acting GnRH agonist delivered as a subcutaneous biodegradable implant. FDA-approved for advanced prostate cancer, advanced breast cancer in premenopausal women, endometriosis, and endometrial thinning prior to ablation.

FDA Approved

Histrelin

Endo Pharmaceuticals' Supprelin LA (pediatric) and Vantas (adult prostate cancer) — a 12-month subcutaneous hydrogel implant delivering histrelin for continuous GnRH-receptor suppression over a full year, minimizing dosing burden for pediatric CPP patients and adult prostate cancer patients alike.

Clinical Trials

Kisspeptin-10

A short active fragment of human kisspeptin — under active clinical investigation for hypothalamic amenorrhea, infertility, and low libido in men and women.

Clinical Trials

Kisspeptin-54

The full-length endogenous kisspeptin, with the most advanced clinical data as an alternative ovulation trigger in IVF that markedly reduces ovarian hyperstimulation syndrome (OHSS) risk.

FDA Approved

Leuprolide

The prototypical long-acting GnRH agonist, FDA-approved across multiple formulations (Lupron Depot, Eligard, Fensolvi, Camcevi) for advanced prostate cancer, endometriosis, central precocious puberty, uterine fibroids, and IVF protocols.

Discontinued

Lutropin alfa

EMD Serono's Luveris — the only recombinant human LH ever FDA-approved (2004, accelerated approval). Discontinued from the US market in 2012; approval formally withdrawn in 2016 after EMD Serono notified the FDA it could not complete the required postmarketing pregnancy-outcome trial.

Research Only

Melanotan II

An unapproved cyclic heptapeptide melanocortin agonist marketed for tanning and sexual function — strongly associated with melanocytic changes and dysplastic nevi in case reports. Not recommended.

FDA Approved

Menotropin

Ferring's Menopur (and earlier Repronex, Humegon) — a urinary-derived FSH/LH combination used for ovulation induction and IVF controlled ovarian stimulation, particularly when LH supplementation is clinically desired.

FDA Approved

Nafarelin

Pfizer's Synarel — the only FDA-approved intranasal GnRH agonist. Approved for endometriosis and central precocious puberty; offers a depot-free alternative to injectable leuprolide for patients who prefer nasal dosing.

FDA Approved

Oxytocin

An endogenous nine-amino-acid hormone with roles in labor, lactation, and social-affiliative behavior; also explored off-label for social/anxiety research.

FDA Approved

PT-141

An FDA-approved melanocortin agonist for acquired, generalized hypoactive sexual desire disorder in premenopausal women.

FDA Approved

Triptorelin

A widely used long-acting GnRH agonist — FDA-approved as Trelstar for advanced prostate cancer and as Triptodur for pediatric central precocious puberty; approved internationally (Decapeptyl, Gonapeptyl) for endometriosis, uterine fibroids, and female infertility protocols.

FDA Approved

Urofollitropin

Ferring's Bravelle (and earlier Fertinex) — highly purified urinary-derived FSH used for ovulation induction and IVF controlled ovarian stimulation. FDA-approved 2002; branded Bravelle was withdrawn from the US market in 2015 due to manufacturing/potency concerns but the molecule class remains available via urinary-derived menotropin combination products.

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