MetabolicNot approvedEvidence tier: Human RCT

Kisspeptin-10

Last updated October 21, 2026. Approval line checked October 21, 2026. Compounding sources checked October 10, 2026.

FDA status

Not approved

Not approved. This record is not an FDA-approved drug product. Approval, where it exists, is specific to a drug product, indication, and route.

FDA primary source on file

Evidence tier

Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 3/5. 890 PubMed citations indexed.

Kisspeptin-10 in the literature

C-terminal decapeptide of kisspeptin-54 acting on GPR54 receptors in the hypothalamus to stimulate GnRH pulse generation and downstream LH/FSH secretion.

What the literature studies

Reproductive Hormone Regulation

Evidence tier

Human RCT

Compounding record

503A Category 2

Confidence
3/5

Regulatory record

503A Category 2. FDA substance context: Kisspeptin-10. 503A Category 2 identifies potential significant safety risks. This is not a drug-product approval or eligibility determination. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.

Regulatory source checked October 10, 2026. This compounding label is separate from the approval line above.

FDA primary source 1

Regulatory context and verification limits are documented below.

Questions

Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.

Short answer

Kisspeptins (KP-54, KP-10) are KISS1-gene peptides that stimulate GnRH/LH; KP-54 has Phase 2 IVF trigger data, but neither KP-10 nor KP-54 is FDA-approved as a drug, and FDA places Kisspeptin-10 in Category 2 for compounding safety concerns.

What it is

Peptides encoded by KISS1 that act on the kisspeptin receptor (KISS1R/GPR54) to drive GnRH release - central to puberty and reproduction [R1]. Research forms include kisspeptin-54 and kisspeptin-10.

Legal / FDA status (as of Oct 27 2026)

Not FDA-approved for infertility, hypogonadism, or any indication. FDA lists Kisspeptin-10 as Category 2 under the 503A interim policy (added Sep 29 2023): immunogenicity/impurity/characterization concerns and "no, or only limited" safety information for proposed routes, so FDA lacks sufficient information to know whether it would cause harm in humans [FDA-RISK]. FDA's Oct 29 2024 PCAC materials evaluated KP-10 nominations and did not support 503A listing on the evidence reviewed [FDA-KP].

Human evidence

  • Kisspeptin-54 as an IVF oocyte-maturation trigger: Phase 2 study in 53 women - mature oocytes obtained across doses; high proportion proceeded to fertilization/embryo transfer with reported clinical pregnancies [R2].
  • Randomized Phase 2 work in women at high OHSS risk reported high oocyte maturation rates without moderate/severe/critical OHSS in that cohort [R3]; related program includes NCT01667406 [R4].
  • Ongoing/completed physiology studies in reproductive disorders (e.g., NCT05633966) explore subcutaneous kisspeptin in hypothalamic amenorrhea - investigational, not approved therapy [R5].
  • Systematic reviews describe clinical status as emerging, not standard of care [R1].

Animal / lab evidence

Foundational rodent/primate reproductive neuroendocrinology. Not a substitute for approved clinical indications.

Risks and unknowns

FDA Category 2 concerns for KP-10 compounding [FDA-RISK]. Injection-site and endocrine effects possible given GnRH-axis stimulation; long-term safety outside trial protocols not established. Gray-market "kisspeptin-10" vials unverified and not equivalent to trial-grade KP-54 protocols.

What's coming

No FDA-approved kisspeptin product identified. Watch reproductive endocrinology trial registries and any compounding-policy updates [OIRA].

Sources

  1. [R1] Prague JK, Dhillo WS. Translating kisspeptin and neurokinin B biology into new therapies for reproductive health. J Neuroendocrinol. doi:10.1111/jne.13201 ; related systematic review PMID 38265397
  2. [R2] Jayasena CN et al. Kisspeptin-54 triggers egg maturation in women undergoing in vitro fertilization. J Clin Invest 2014;124:3667-3677. doi:10.1172/JCI75730 ; PMC4109525
  3. [R3] Abbara A et al. Efficacy of Kisspeptin-54 to Trigger Oocyte Maturation in Women at High Risk of OHSS During IVF. J Clin Endocrinol Metab 2015. PMID 26192876
  4. [R4] ClinicalTrials.gov NCT01667406. The Use of the Hormone Kisspeptin in IVF Treatment. https://clinicaltrials.gov/study/NCT01667406
  5. [R5] ClinicalTrials.gov NCT05633966. Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders. https://clinicaltrials.gov/study/NCT05633966
  6. [FDA-RISK] FDA. Certain Bulk Drug Substances... (Kisspeptin-10 Category 2 entry). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  7. [FDA-KP] FDA. October 29, 2024 PCAC meeting materials (kisspeptin-10 evaluation). https://www.fda.gov/media/182089/download
  8. [OIRA] OIRA. Pending EO 12866 Review, RIN 0910-ZD94. https://www.reginfo.gov/public/do/eoDetails?rrid=1568964

Last checked 2026-10-27

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