Kisspeptin-10

Not FDA-approved FDA risk list (Category 2)

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA

Randomized controlled trials 5 of 318 publications on PubMed

Registered clinical trials 5 0 active

Adverse event reports 1 1 classified as serious

Kisspeptin-10 is not an FDA-approved drug: Drugs@FDA has no record of it.
FDA lists it in Category 2, bulk substances that may present significant safety risks in compounding (since September 29, 2023).
PubMed lists 318 publications mentioning it, including 5 randomized controlled trials and 172 animal-only studies.
ClinicalTrials.gov lists 5 registered studies testing it (0 active).
FDA's adverse event system (FAERS) holds 1 report mentioning it; 1 classified as serious. Reports do not prove causation.

Research topics

Kisspeptins 162
Receptors, Kisspeptin-1 36
Luteinizing Hormone 35
Gonadotropin-Releasing Hormone 30
Receptors, G-Protein-Coupled 21
Neurons 20
Estradiol 17
Cell Proliferation 16
RNA, Messenger 15
Reproduction 15

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

FDA risk list (Category 2) Applies to: 503A Added: September 29, 2023

FDA's stated risk · Original FDA text (English) Compounded drugs containing Kisspeptin-10 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has no, or only limited, safety-related information for the proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm when administered to humans.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

All publications 318
Human (MeSH) 110
Animal only 172
Clinical trials 9
Randomized controlled trials 5
Systematic reviews & meta-analyses 0
Case reports 0
Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Kisspeptin-10/basal LH ratio improves differentiation of central precocious puberty and premature thelarche. Human study 2027 Clinica chimica acta; international journal of clinical chemistry
Regulation of PACAP gene expression by ovarian sex steroids and kisspeptin: Study using hypothalamic cell lines and an in vivo female rat model. Unclassified 2026 Biochemistry and biophysics reports
Kisspeptin-10 alleviates OGD/R-induced H9c2 cardiomyocyte injury by triggering autophagy via regulating the YY1/TFEB axis. Unclassified 2026 Cytotechnology
Kisspeptin-10 Alleviates Obesity-induced Testicular Oxidative Stress and Mitochondrial Dysfunction via Modulation of Mitophagy and Autophagy Signaling. Unclassified 2026 Reproductive sciences (Thousand Oaks, Calif.)
Enzymatic Stability and Comparative Effects of Kisspeptin-14, Kisspeptin-13 and Kisspeptin-10 on Beta-Cell Function, Glucose Homeostasis and Appetite Regulation. Unclassified 2026 Metabolites
Maternal Kisspeptin-10 Treatment Partially Rescues Fetal and Postnatal Cardiac Programming Disrupted by Maternal Hypothyroidism. Animal study 2026 Cardiovascular toxicology
Structural basis for Kisspeptin-10 selectivity toward KISS1R: computational insights. Unclassified 2026 In silico pharmacology
Kisspeptin System: A Modulator of Neuroinflammation and Behaviour in Temporal Lobe Epileptic Rats. Animal study 2026 Molecular neurobiology
Chronic subcutaneous kisspeptin-10 stimulates gonadotropin secretion for 12 days in healthy men. Randomized controlled trial 2026 European journal of endocrinology
The kisspeptin analog C6 elicits greater tachyphylaxis and transcriptional activation than kisspeptin-10 and -54. Human study 2026 Molecular and cellular endocrinology

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered: 5
Active: 0
With posted results: 0

Conditions studied

Metabolic Disease 1
Insulin 1
Glucose 1
Healthy Volunteers 1
Women 1
Pregnancy 1
Sterility, Reproductive 1
Reproductive Physiological Phenomena 1
Kisspeptin Action on Insulin in Healthy Normal Men 1
Kisspeptin Action on Insulin in Obese Diabetic Men 1

Study	Status	Phase	Start
Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp NCT05456854 Massachusetts General Hospital	Withdrawn	Phase 1	June 3, 2022
Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance NCT04532801 Stephanie B. Seminara, MD	Withdrawn	Phase 1	September 1, 2019
Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis in Men NCT03315325 Quaid-e-Azam University	Completed	Phase 3	August 8, 2014
Link Between the Sensitivity of Kisspeptin Signalling and Pubertal Onset in Boys. NCT03286517 Ghulam Nabi	Completed	Phase 3	June 26, 2014
KP-10 and Insulin Secretion in Men NCT03771326 Quaid-e-Azam University	Completed	Phase 3	October 29, 2013

All 5 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports: 1
Serious: 1
With death outcome: 0

Most reported reactions

Oestrone increased 1
Weight increased 1

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.