Evidence Grade B — Strong clinical evidence. 3241 published studies, 1187 human. 29 registered clinical trials.
Medically reviewed by a licensed medical professional
This entry covers clinical development programmes for kisspeptin-based treatments — a natural brain hormone that controls the reproductive hormone cascade. The most advanced use is in IVF, where kisspeptin triggers egg maturation without the ovarian hyperstimulation syndrome (OHSS) risk that makes current IVF triggers dangerous for some women. No kisspeptin product is yet approved.
Kisspeptin (Clinical Formulations) is also known by these brand and alternate names:
3,241 published studies: 1187 human, 1637 animal, 353 in-vitro, 740 reviews
Clinical kisspeptin programmes represent the most advanced effort to translate kisspeptin biology into a pharmaceutical product. A Phase II IVF trial (60 high-risk patients) achieved 95% oocyte maturation with zero cases of moderate, severe, or critical ovarian hyperstimulation syndrome — the most serious complication of IVF. Live birth rates of 45% per transfer were achieved at the optimal dose.
MVT-602 completed Phase IIa in IVF (60 patients) showing non-inferior oocyte maturation versus the standard GnRH agonist trigger but with a more physiological hormonal profile. The potential to eliminate ovarian hyperstimulation syndrome in high-risk IVF patients represents a significant unmet clinical need. See also kisspeptin-10 (#130) and kisspeptin-54 (#131).
Kisspeptin activates the KISS1R receptor on GnRH neurons, triggering a physiological LH surge for egg maturation in IVF. The resulting hormone response is more natural in amplitude and duration than conventional IVF triggers, which may explain the reduced risk of ovarian hyperstimulation syndrome. MVT-602 achieves a similar physiological response with a longer duration of action.
A Phase II IVF trial at Imperial College London achieved 95% egg maturation with zero cases of moderate, severe, or critical ovarian hyperstimulation syndrome in 60 high-risk patients. Live birth rates of 45% per transfer were achieved at the optimal dose. A longer-acting synthetic version (MVT-602) showed similar results in 60 patients. The potential to eliminate OHSS in high-risk IVF patients addresses a genuine safety gap, but sample sizes remain small and no Phase III trial has been announced. Commercial development timelines are uncertain — the companies involved have other priorities. An intranasal formulation demonstrated in 2025 could improve accessibility if developed further. The kisspeptin pathway also has research interest in conditions like hypothalamic amenorrhoea (loss of periods due to stress or low weight).
PeptideTrace tracks 29 registered clinical trials for Kisspeptin (Clinical Formulations) sourced from ClinicalTrials.gov.
Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease
Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
Functional Proteins in Polycystic Ovary Syndrome
Kissing as a Protective Factor Against Acidic pH in Saliva
A Prospective Cohort Study on the Serum Kisspeptin Levels Throughout Pregnancy in PCOS
Clinical-grade kisspeptin-54 is a 54-amino-acid neuropeptide with molecular weight approximately 5.9 kDa acting at the KISS1R (GPR54) receptor. MVT-602 is a synthetic longer-acting kisspeptin receptor agonist developed by Myovant Sciences (now Sumitovant Biopharma, acquired March 2023 for approximately $1.7 billion). This entry covers formalized clinical development programs for kisspeptin-based therapeutics, primarily led by the Imperial College London research group (Dhillo and Abbara), distinct from research-grade kisspeptin-54 (compound 131) and kisspeptin-10 (compound 130).
Kisspeptin-54 agonizes hypothalamic KISS1R receptors on GnRH neurons, triggering pulsatile GnRH release and inducing an endogenous LH surge for oocyte maturation in assisted reproduction. The resulting LH surge is physiological in amplitude (peak approximately 41 IU/L at 4 hours) compared with the supraphysiological response from GnRH agonist triggers (approximately 140 IU/L), dramatically reducing the risk of ovarian hyperstimulation syndrome (OHSS). Additional mechanisms may include direct ovarian KISS1R-mediated reduction in VEGF release.
Phase 2 IVF trial (Abbara et al., 2015; NCT01667406; N=60 high-OHSS-risk women): oocyte maturation in 95% of patients; live birth rate 45% per transfer (62% at optimal 9.6 nmol/kg dose); zero cases of moderate, severe, or critical OHSS. Phase 2 double-dose RCT (N=62): oocyte yield of at least 60% achieved in 71% (double dose) versus 45% (single dose; P=0.042). Retrospective OHSS comparison (N=261): odds ratio for OHSS was 33.6 times higher with hCG versus kisspeptin and 3.6 times higher with GnRH agonist versus kisspeptin. MVT-602 Phase 1/2a: LH AUC was 4.4 times greater than kisspeptin-54, with delayed peak (21.4 hours versus 4.7 hours; P=0.0002). An intranasal kisspeptin formulation was successfully demonstrated for the first time (eBioMedicine 2025).
The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.
Carbetocin has not been approved by the FDA. It is registered in over 80 countries for prevention of uterine atony and excessive bleeding after caesarean delivery. A heat-stable formulation was added to the WHO Essential Medicines List in 2019. The CHAMPION trial (WHO, 2018; over 29,000 women) compared a heat-stable carbetocin formulation to oxytocin for preventing postpartum haemorrhage after vaginal delivery, and found it to be non-inferior. The heat-stable formulation addresses a significant limitation of oxytocin, which degrades in warm climates without refrigeration — a major concern in low-resource settings where postpartum haemorrhage causes the most deaths. Its regulatory status varies by jurisdiction.
Kisspeptin-54 has no marketing authorisation. Phase II trials conducted primarily at Imperial College London have investigated its use as an IVF oocyte maturation trigger. One trial (60 patients) reported 95% oocyte maturation with zero cases of ovarian hyperstimulation syndrome. Kisspeptin-54 has a more advanced clinical evidence base than kisspeptin-10, with multiple Phase II studies in reproductive medicine. Its potential advantage over conventional IVF triggers relates to a lower risk of the serious complication of ovarian hyperstimulation. Clinical development is ongoing in academic settings. No Phase III trials have been completed.
Goserelin is marketed as Zoladex by AstraZeneca, available as 3.6 mg monthly and 10.8 mg three-monthly subcutaneous implants. First approved in 1989, it is used in advanced prostate cancer, premenopausal breast cancer, endometriosis, and for thinning the uterine lining before surgical procedures. Goserelin achieves castrate-level testosterone suppression (below 50 ng/dL) within two to four weeks. Its unique implant delivery system means there is no liquid injection, reconstitution, or refrigeration required — a practical advantage in some clinical settings. Like all GnRH agonists, it causes an initial hormone flare before suppression takes effect. Goserelin holds an important niche in breast cancer treatment, where it is used to suppress ovarian function in premenopausal women with hormone-receptor-positive disease, often in combination with aromatase inhibitors.
This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.
