Kisspeptin-10
Also sold as: KP-10, Kisspeptin-112-121, Metastin 45-54, KISS1 (112-121)
Kisspeptin-10 is in FDA's 503A Category 2 — bulk drug substances that raise significant safety risks — on the list updated 2026-05-14, FDA's Pharmacy Compounding Advisory Committee voted 0-11 against adding kisspeptin-10 to the 503A bulks list on 2024-10-29, and FDA has recorded that there is no approved product in any country containing kisspeptin-10. Kisspeptin-10 has genuinely been administered to humans — FDA counted approximately 300 subjects across small studies, a figure FDA flagged may be an overestimate, so this is not a compound with zero human exposure — but that exposure is essentially all intravenous: FDA found no study administering kisspeptin-10 to humans intramuscularly and a single subcutaneous study, in healthy women, that did not report safety outcomes, while intramuscular and subcutaneous are the routes kisspeptin-10 was nominated for. FDA's own conclusion is that “there is insufficient evidence to make a conclusion on the effectiveness of kisspeptin-10 as a treatment option for men with secondary hypogonadism.”
Which molecule this is. The C-terminal decapeptide of the KISS1 gene product, and the shortest fragment retaining full agonist activity at the kisspeptin receptor (KISS1R/GPR54). It is one of several endogenous kisspeptin isoforms; kisspeptin-54 (metastin) is a distinct, longer isoform. THE ISOFORM IS LOAD-BEARING, in the same way full-length Tβ4 versus the 17-23 fragment is load-bearing for TB-500. The human studies most often invoked to sell kisspeptin-10 — the randomised trial in men with hypoactive sexual desire disorder and the sexual-brain-processing fMRI work (Comninos, Abbara and colleagues at Imperial College London) — administered KISSPEPTIN-54, not kisspeptin-10. Verified 2026-07-16. Only FDA's Category 2 listing and the gonadotrophin studies below are scoped to kisspeptin-10 itself.
FDA status
FDA has not approved this and it is not in active development toward approval. That says nothing about whether it is being sold — most substances in this category are.
Not an FDA-approved drug for any indication, and not in active development toward approval. That says nothing about whether it is sold — it is.
“503A Category 2: Bulk Drug Substances that Raise Significant Safety Risks”Checked against the source on .
503A compounding
FDA has identified significant safety risks with this substance.
Verified by fetching and text-extracting the list updated 2026-05-14 directly. Kisspeptin-10 is one of exactly six substances in Category 2 — with Cesium Chloride, Domperidone, Germanium Sesquioxide, Ibutamoren Mesylate, and Quinacrine Hydrochloride for intrauterine administration. This is the atypical case in this library: it did NOT leave Category 2 by withdrawal the way BPC-157, TB-500, epitalon, semax, MOTS-c, KPV and DSIP did. It is still listed, under the heading naming significant safety risks, and it is not on the 503A bulks list. Category 2 is nevertheless not the criminal line either: the Watkins indictment (D. Utah, 1:26-cr-00015, 2026-04-01) charges misbranding under 352(b), which is why Category 1 substances sit in the same indictment as substances that were never listed at all. Sourcing and labeling are the line.
“503A Category 2: Bulk Drug Substances that Raise Significant Safety Risks”Checked against the source on .
Evidence
There is human data, but efficacy is not established. This includes programmes that were tested and failed.
Administration check run per study, not inferred from counts. In a 2011 study, George, Veldhuis, Roseweir and colleagues administered kisspeptin-10 to six healthy men as ascending intravenous boluses against a saline vehicle. CORRECTION, 2026-07-16: this note previously said the dose order was 'randomised and blinded'. The paper says the opposite on the first half — 'Doses were administered in increasing order for safety reasons and visits were at least 1 wk apart' — and the blinding it reports is of participants only: 'Participants were blinded to the dose of kisspeptin-10.' The researchers reported a rise in serum LH that did NOT increase monotonically with dose, and the authors' finding at the top of the range is stronger than this note previously allowed: 'There was, however, no significant increase in LH concentration after the highest dose administered …, and the mean LH after this dose was significantly less than after the …' two lower doses it names. Not merely a reduced response at the top dose — no significant increase over vehicle at all. In a 2015 single-blinded, placebo-controlled study, Jayasena and colleagues infused kisspeptin-10 intravenously into healthy men and reported gonadotrophin secretion similar to kisspeptin-54 but lower than GnRH. Both papers were opened and both ADMINISTERED the compound — this is real human exposure data, unlike MOTS-c or TB-500. CORRECTION, 2026-07-16: this note previously said the exposure was confined to 'single-digit cohorts of healthy male volunteers'. That understated it. FDA's 2024 PCAC briefing document counts approximately 300 subjects across the published studies, including men and women with idiopathic hypogonadotropic hypogonadism, men with type 2 diabetes and low testosterone, women with hyperprolactinemia, and adolescents with delayed puberty — patients, not only healthy volunteers. See fdaFindings. The tier stops at promising-but-unproven anyway, and for the reason FDA gives rather than the one this note originally gave: the endpoints are PHARMACODYNAMIC (serum LH, FSH, testosterone) and the studies are, in FDA's word, exploratory. Limitations, per the authors: n=6 and n=4 respectively for the 2011 dose-response and infusion arms; n=5 per group in 2015; healthy volunteers rather than patients; and the 2011 authors could not measure serum kisspeptin-10 concentrations owing to suboptimal sample processing. No adequate, well-controlled trial reports a clinical outcome for kisspeptin-10 in any patient population, and moving a hormone in healthy volunteers is not a demonstration that a treatment works.
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
FDA placed Kisspeptin-10 in 503A Category 2 — bulk drug substances that raise significant safety risks — on 2023-09-29, and it remains listed there as of the list updated 2026-05-14.
Note what FDA's finding is and is not. It is not a finding that kisspeptin-10 was shown to harm anyone; it is a finding that FDA cannot tell, and that the manufacturing and characterisation problems are real. FDA's own next sentence is explicit: it has 'no, or only limited, safety-related information for the proposed routes of administration' and 'lacks sufficient information to know whether the drug would cause harm when administered to humans.' An evidentiary vacuum, recorded as a risk — not a loophole.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 29 September 2023“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.”
Checked against the source on .The Category 2 safety risks FDA identified for Kisspeptin-10 are scoped to the 503A compounding pathway only; FDA lists no 503B date for the substance.
Recorded because the table distinguishes 503A from 503B per substance — ipamorelin acetate, the row directly above it, carries a 503B date alone, and ibutamoren mesylate carries both ('503A; 503B'). Kisspeptin-10's row reads 503A alone. CORRECTION, 2026-07-16: this note previously named ibutamoren mesylate as the row directly above and as the 503B-only comparator; it is two rows up and it carries both, which collapsed the intended contrast. The claim the note exists for — that kisspeptin-10's row reads 503A alone — is unaffected and verified against the list.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 29 September 2023Checked against the source on .FDA proposed not adding kisspeptin-10 to the 503A bulks list, and on 2024-10-29 its Pharmacy Compounding Advisory Committee voted 0 yes, 11 no, 0 abstain against placing kisspeptin-10 on that list.
This is the finding the previous revision of this record denied existed. Read the vote precisely. It is not 11 people disliking a peptide: the question put to the committee was FDA's own proposal, the nominator (Farmakeio/Evexias) was invited to present and did, two temporary voting members were seated for the kisspeptin-10 topic alone (Joseph P. Alukal, MD; Roger R. Dmochowski, MD), and the result was still unanimous. Compare the same day's other votes, which were NOT unanimous — L-theanine 1-12, ibutamoren mesylate 1-13, ipamorelin 0-12-1. Kisspeptin-10 drew the only clean sweep of the four substances heard. Note also what a PCAC vote is not: it is advisory, and as of the bulks list updated 2026-05-14 no final rule under 21 CFR 216.23 has issued for kisspeptin-10 either way — the substance sits in Category 2, still, not on a final not-included list.
Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024“VOTE: FDA is proposing that Kisspeptin-10 NOT be included on the 503A Bulks List. Should Kisspeptin-10 be placed on the list? Vote Result: Yes: 0 No: 11 Abstain: 0 … The committee unanimously agreed that Kisspeptin-10 should not be included on the 503A Bulks List due to the lack of convincing safety and efficacy data.”
Checked against the source on .FDA's stated basis for proposing not to add kisspeptin-10 was four-fold: poor physicochemical characterization, absent immunogenicity information, insufficient effectiveness evidence, and the existence of approved alternatives for the proposed indication.
The fourth limb is the one that never appears on a vendor page and is the most decision-relevant of the four. FDA is not saying nothing works for this condition — it is saying something already does: 'there are FDA-approved drug products that are indicated to treat secondary hypogonadism, a potentially serious condition.' The compounding question is therefore not 'is kisspeptin-10 better than nothing' but 'is an uncharacterised bulk substance better than an approved product for a serious condition', which is a materially harder question and the one FDA actually answered.
FDA Briefing Document — Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 (Kisspeptin-10, evaluated for the treatment of secondary hypogonadism in men) — FDA, 29 October 2024“On balance, the physicochemical characterization, information on historical use, evidence of effectiveness, and safety information identified for kisspeptin-10 weigh against inclusion of this substance on the 503A Bulks List. In particular, FDA's proposal regarding this substance is based on the fact that kisspeptin-10 is not well characterized from a physicochemical perspective, there is a lack of information on immunogenicity risks, there is insufficient evidence to make a conclusion on the effectiveness of kisspeptin-10 as a treatment option for men with secondary hypogonadism, and there are FDA-approved drug products that are indicated to treat secondary hypogonadism, a potentially serious condition. Accordingly, we propose not adding kisspeptin-10 to the 503A Bulks List.”
Checked against the source on .FDA recorded that no product containing kisspeptin-10 is approved anywhere in the world, and that kisspeptin-10 does not appear in the European or Japanese Pharmacopeias.
Worth having in this exact form because the usual deflection is jurisdictional — 'it's approved in Europe / Japan / somewhere.' FDA closed that door in one sentence, and it closed the compendial door in the same sentence. The pharmacopeia half is not decoration: under section 503A a bulk substance that is the subject of an applicable USP or NF monograph can be compounded WITHOUT appearing on the bulks list, so the absence of a monograph is precisely why the bulks-list question is dispositive here.
FDA Briefing Document — Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 (Kisspeptin-10, evaluated for the treatment of secondary hypogonadism in men) — FDA, 29 October 2024“There is no approved product in any country containing kisspeptin-10 at this time, nor is kisspeptin-10 found in the European or Japanese Pharmacopeias.”
Checked against the source on .FDA identified several small studies that administered kisspeptin-10 to humans, totalling approximately 300 subjects across intravenous and subcutaneous routes — and flagged that figure as possibly an overestimate. That exposure is essentially all intravenous: FDA found no human study by the intramuscular route, and a single subcutaneous study, in approximately 35 healthy women, that reported no safety outcomes.
Recorded as an explicit POSITIVE, and it is the finding that separates this record from the house pattern. FDA's characteristic sentence for the peptides in this library is 'we have not identified any human exposure data'. It did not write that here, because it could not. Per FDA's own count kisspeptin-10 has been given to roughly 300 people, including men and women with idiopathic hypogonadotropic hypogonadism, men with type 2 diabetes and low testosterone, women with hyperprolactinemia, and adolescents with delayed puberty — so the exposure extends beyond healthy volunteers, which corrects this record's earlier evidence note. Anyone citing this site for 'no human data on kisspeptin-10' is citing it wrongly. What FDA concluded from those 300 is the next finding, and it is the part that matters.
FDA Briefing Document — Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 (Kisspeptin-10, evaluated for the treatment of secondary hypogonadism in men) — FDA, 29 October 2024“We identified several small studies that administered kisspeptin-10 to humans. … Based on these studies, kisspeptin-10 has been administered via the IV and SC ROA to approximately 300 subjects … This may be an overestimate as it is unclear if there is overlap in subjects between the studies. … Kisspeptin-10 was nominated for SC and IM administration. We found no studies that administered kisspeptin-10 to humans via the IM ROA. We identified a single study that administered a single SC bolus of kisspeptin-10 to approximately 35 healthy women. Safety outcomes were not reported in this study.”
Checked against the source on .FDA concluded that there is insufficient evidence to reach a conclusion on the effectiveness of kisspeptin-10 for secondary hypogonadism in men — the only use it evaluated — and that no study administered kisspeptin-10 by the proposed routes in men with hypogonadism.
The single most citable sentence available about this compound, and the one that resolves the apparent contradiction with the finding above. Roughly 300 people received it; FDA read the whole set and still could not get to an effectiveness conclusion. 'Exploratory' is the operative word — these were mechanism studies, not treatment trials. And note the route gap, which is the sharpest fact on this page: every human study FDA found used the intravenous route (plus one subcutaneous study in healthy women), while the NOMINATED routes were intramuscular and subcutaneous. FDA found no study at all administering kisspeptin-10 intramuscularly to humans. Kisspeptin-10 sold for self-injection is therefore being used by a route for which the human literature FDA assembled is essentially empty — the published infusions do not transfer to it.
FDA Briefing Document — Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 (Kisspeptin-10, evaluated for the treatment of secondary hypogonadism in men) — FDA, 29 October 2024“There is insufficient evidence to make a conclusion on the effectiveness of kisspeptin-10 as a treatment option for men with secondary hypogonadism. It is not possible to draw any meaningful conclusions on effectiveness from the studies identified in this evaluation due to the small number of subjects included, the exploratory nature of the studies, and the dosing of kisspeptin-10 (ROA and frequency of administration) used in the studies. We are not aware of studies that administered kisspeptin-10 via the proposed routes of administration (IM or SC) in men with hypogonadism. In addition, it is unclear if chronic IV administration of kisspeptin-10 would confer any clinical benefit in this patient population.”
Checked against the source on .FDA found kisspeptin-10 is not well characterized from a physical and chemical perspective, because impurity data for it were absent both from the published literature and from the certificate of analysis supplied with the nomination.
This is a finding about the PAPERWORK, and that is what makes it damning rather than pedantic. The certificate of analysis is the document a seller points to when asked to prove what is in the vial. FDA looked at the CoA the nominator itself chose to submit in support of its own nomination, and found it did not establish the impurity profile. A CoA from a research-peptide vendor is not a stronger document than the one FDA rejected here.
FDA Briefing Document — Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 (Kisspeptin-10, evaluated for the treatment of secondary hypogonadism in men) — FDA, 29 October 2024“the nominated BDS, kisspeptin-10, is not well characterized from the physical and chemical characterization perspective because certain critical characterization data specific to kisspeptin-10, such as likely impurities, were neither found in the publicly available scientific literature nor they were provided in the CoA, which are offered as evidence to establishing identity, purity, and impurity profiles of kisspeptin-10.”
Checked against the source on .FDA's interim policy extends its stated enforcement forbearance only to 503A Category 1 substances; substances placed in Category 2 are expressly outside it.
Recorded because it is the sentence that converts a category label into a consequence, and this record would be decorative without it. The Category 1 policy is a promise not to act: FDA 'does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician' compounding with such a substance, subject to four conditions — the first of which is literally that 'the bulk drug substance appears in 503A Category 1 on FDA's website.' Kisspeptin-10 fails condition one. The guidance also states the baseline that then applies: a drug product compounded from a bulk substance that is neither on the 503A bulks list, nor the subject of an applicable USP or NF monograph, nor a component of an FDA-approved drug 'is not eligible for the exemptions in section 503A and may violate the FD&C Act.' None of the three is true of kisspeptin-10. Read this against the WITHDRAWN compounds in this library, where the market's inference runs the other way: withdrawal removes a substance from the categories and therefore from the Category 1 forbearance too, so leaving the list moves a compound sideways or backwards, never toward legality.
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act — Guidance for Industry — FDA, 7 January 2025“503A Category 2 – Substances Nominated for the Bulks List That Raise Significant Safety Risks: These substances were nominated with sufficient supporting information to permit FDA to evaluate them, and they may be eligible for inclusion on the 503A bulks list. However, FDA has identified significant safety risks relating to the use of these substances in compounding pending further evaluation and, therefore, does not intend to adopt the policy described for the substances in Category 1.”
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Documented safety signals
FDA identified immunogenicity risk for certain routes of administration, plus complexities in peptide-related impurities and active pharmaceutical ingredient characterization.
This is the same immunogenicity-plus-characterisation language FDA applies to BPC-157 and other peptides, and it is a statement about the SUBSTANCE AS COMPOUNDED — impurity profile and API identity — not about the molecule as studied under IND in the published infusion work. What arrives from a research-peptide vendor is not what was infused in those studies, and FDA's finding is squarely about the former.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 29 September 2023“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.”
Checked against the source on .No adverse-event signal specific to kisspeptin-10 was identified in the FDA Category 2 summary; the listed basis is absence of safety information rather than observed harm.
Recorded as an explicit negative so the gap is visible rather than silently absent. Contrast the neighbouring Category 2 entries, where FDA does cite observed harm: ibutamoren mesylate carries a trial 'terminated early due to a potential safety signal of congestive heart failure'. Kisspeptin-10's entry carries no equivalent. CORRECTION, 2026-07-16: this note previously continued 'FDA has not published a PCAC briefing document for kisspeptin-10 … so no FAERS review of the kind available for BPC-157 exists for this compound.' Both halves were false. FDA published a 64-page briefing document for the 2024-10-29 PCAC meeting, and it contains a full FAERS review. The error was inferring absence-from-the-2026-docket to absence-from-the-record; the kisspeptin-10 evaluation simply happened in 2024. See the FAERS finding below.
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — FDA, 29 September 2023Checked against the source on .A search of FAERS through 2023-10-25 retrieved exactly one adverse-event report for kisspeptin-10, and a search of CAERS retrieved zero.
One report is not a clean safety record and must not be read as one — FDA says so itself in the same passage, noting it 'does not receive all adverse event reports that may potentially occur with a product, especially for compounded products.' A compound sold outside the prescribing system generates almost no reports precisely BECAUSE it is sold outside the system: there is no prescriber to file. The single report concerned a 17-year-old male with hypogonadotropic hypogonadism given a compounded injectable kisspeptin-10 product (Tailor Made Compounding) subcutaneously over roughly six weeks to stimulate testosterone production; the reported outcome was weight gain and increased estrone — 'which were not the desired effects' — and FDA notes the case is limited by unclear temporal relationship and insufficient information. FDA's separate safety conclusion is the one to quote: 'Based on available data, there is a lack of information about whether kisspeptin-10 can be safely used in the intended population, the appropriate dose range, and frequency and duration of dosing for the proposed routes of administration.' Note that FDA reported no reported compounded drug products containing kisspeptin-10 in its outsourcing-facility product reporting data from January 2017 to June 2023 — the 503B channel was not making this, which is consistent with kisspeptin-10's row on the Category 2 table reading 503A alone.
FDA Briefing Document — Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 (Kisspeptin-10, evaluated for the treatment of secondary hypogonadism in men) — FDA, 29 October 2024“The Office of Surveillance and Epidemiology conducted a search of the FAERS database for reports of adverse events (AEs) for kisspeptin-10 through October 25, 2023. The search retrieved one report … Considering these limitations, FDA cannot make definitive conclusions regarding the safety of kisspeptin-10 based on FAERS data alone.”
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Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is kisspeptin-10 legal in 2026?
No — kisspeptin-10 has no lawful route into pharmacy compounding in the United States as of July 2026, and a product compounded with it may violate federal law. Kisspeptin-10 is not on FDA's 503A bulks list, is not the subject of a USP or NF monograph, and is not a component of any FDA-approved drug product, and FDA's guidance states that a drug product compounded from a bulk drug substance meeting none of those three conditions “is not eligible for the exemptions in section 503A and may violate the FD&C Act.” FDA's interim enforcement policy — under which it says it does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician compounding with a nominated substance — requires that the substance appear in 503A Category 1. Kisspeptin-10 is in 503A Category 2, which FDA describes as substances that raise significant safety risks and for which it “does not intend to adopt the policy described for the substances in Category 1.”
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act — Guidance for Industry — FDA, 7 January 2025“A drug product compounded from a bulk drug substance that does not meet any of these three conditions is not eligible for the exemptions in section 503A and may violate the FD&C Act.”
Checked against the source on .- Did kisspeptin-10 become legal when FDA removed it from Category 2?
FDA has not removed kisspeptin-10 from Category 2 — the premise is false. Kisspeptin-10 is one of exactly six substances still listed in 503A Category 2 on FDA's bulk drug substances list updated 2026-05-14, alongside cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, and quinacrine hydrochloride for intrauterine administration. Kisspeptin-10 is frequently confused with the peptides whose nominations were withdrawn by their nominators — BPC-157, TB-500, epitalon, semax, MOTS-c, KPV and DSIP among them — but kisspeptin-10 is not one of them and remains listed under the heading naming significant safety risks. Withdrawal would not have made kisspeptin-10 legal in any event: leaving the categories also removes a substance from the Category 1 enforcement policy, which is the only forbearance FDA's interim guidance offers.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026“503A Category 2: Bulk Drug Substances that Raise Significant Safety Risks … Cesium Chloride … Domperidone … Germanium Sesquioxide … Ibutamoren Mesylate … Kisspeptin-10 … Quinacrine Hydrochloride for intrauterine administration”
Checked against the source on .- Did FDA approve kisspeptin-10?
No. FDA has not approved kisspeptin-10 for any indication, and in its briefing document for the 2024-10-29 Pharmacy Compounding Advisory Committee meeting FDA stated that “there is no approved product in any country containing kisspeptin-10 at this time, nor is kisspeptin-10 found in the European or Japanese Pharmacopeias.” The only regulatory question FDA has evaluated for kisspeptin-10 is a narrower one — whether it may be used as a bulk drug substance in pharmacy compounding under section 503A — and FDA proposed not adding it to that list.
FDA Briefing Document — Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 (Kisspeptin-10, evaluated for the treatment of secondary hypogonadism in men) — FDA, 29 October 2024“There is no approved product in any country containing kisspeptin-10 at this time, nor is kisspeptin-10 found in the European or Japanese Pharmacopeias.”
Checked against the source on .- Is there any human evidence that kisspeptin-10 works?
Kisspeptin-10 has been administered to humans — FDA identified several small studies totalling approximately 300 subjects, a figure FDA flagged may be an overestimate because subjects may overlap between studies, so unlike many peptides sold alongside it, kisspeptin-10 is not a compound with zero human exposure data. That exposure is essentially all intravenous, though: FDA found no study that administered kisspeptin-10 to humans intramuscularly, and a single subcutaneous study, a one-off bolus in about 35 healthy women, in which safety outcomes were not reported — and subcutaneous and intramuscular are the routes kisspeptin-10 was nominated for and is sold for self-injection. But it has not been shown to work. Having reviewed those studies, FDA concluded that “there is insufficient evidence to make a conclusion on the effectiveness of kisspeptin-10 as a treatment option for men with secondary hypogonadism,” and that it was “not possible to draw any meaningful conclusions on effectiveness from the studies identified in this evaluation due to the small number of subjects included, the exploratory nature of the studies,” and the routes and frequencies used. In the published human work FDA reviewed, the measured endpoints are short-term hormone responses such as serum luteinising hormone, not clinical outcomes — and FDA reported that even the hormone response does not carry through to the thing men would be taking it for: “transient rises in LH response to acute kisspeptin-10 administration are not associated with sustained increases in testosterone. Thus, even if kisspeptin-10 induces an LH response in men, it is unclear if there are corresponding increases in testosterone levels.”
FDA Briefing Document — Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 (Kisspeptin-10, evaluated for the treatment of secondary hypogonadism in men) — FDA, 29 October 2024“There is insufficient evidence to make a conclusion on the effectiveness of kisspeptin-10 as a treatment option for men with secondary hypogonadism. … Additionally, George et al. (2013) notes that transient rises in LH response to acute kisspeptin-10 administration are not associated with sustained increases in testosterone. Thus, even if kisspeptin-10 induces an LH response in men, it is unclear if there are corresponding increases in testosterone levels.”
Checked against the source on .- What did FDA's advisory committee decide about kisspeptin-10?
FDA's Pharmacy Compounding Advisory Committee voted unanimously against kisspeptin-10 on 2024-10-29 — 0 yes, 11 no, 0 abstain — on the question of whether kisspeptin-10 should be placed on the 503A bulks list. The committee's recorded reason was “the lack of convincing safety and efficacy data,” and the use FDA had evaluated was the treatment of secondary hypogonadism in men. The nominator was invited to present in support of the nomination and did so, and the vote was still unanimous; of the four bulk drug substances the committee heard that day, kisspeptin-10 was the only one to draw a unanimous vote. A PCAC vote is advisory, and as of FDA's bulks list updated 2026-05-14 kisspeptin-10 remains in 503A Category 2 pending a final rule.
Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, October 29, 2024 — FDA, 29 October 2024“VOTE: FDA is proposing that Kisspeptin-10 NOT be included on the 503A Bulks List. Should Kisspeptin-10 be placed on the list? Vote Result: Yes: 0 No: 11 Abstain: 0 … The committee unanimously agreed that Kisspeptin-10 should not be included on the 503A Bulks List due to the lack of convincing safety and efficacy data.”
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