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FDA Category 2 · restricted from compounding

This compound is on the FDA’s interim Section 503A Category 2 bulks list and cannot be legally compounded by US pharmacies. An HHS announcement in February 2026 signaled intent to restore several peptides to Category 1, but no Federal Register action has been published. Check the FDA PCAC schedule for updates.

Read the full regulatory context
ClinicalSexual HealthSubQTrial-dependent

Kisspeptin

KP-10 · KP-54 · metastin

Upstream driver of pulsatile GnRH release; investigational for HSDD, functional hypothalamic amenorrhea, and OHSS-free oocyte triggering in IVF.

Read dosing protocolJump to references

§ 01   Overview

Overview

Upstream driver of pulsatile GnRH release; investigational for HSDD, functional hypothalamic amenorrhea, and OHSS-free oocyte triggering in IVF.

Dhillon Dhillo Lab (Imperial) has run multiple Phase 2 studies.

§ 02   Mechanism

Mechanism of action

Kisspeptin (from the KISS1 gene) binds KISS1R/GPR54 on hypothalamic neurons to drive pulsatile GnRH release. It sits upstream of the entire HPG axis and is a candidate for conditions where pulsatile LH/FSH is needed without supraphysiological triggering.

  • 01OHSS-free oocyte maturation in IVF
  • 02Arousal effects (HSDD Phase 2)
  • 03Restoration of cyclicity in hypothalamic amenorrhea

§ 03   Dosing

Dosing protocol

Standard Protocol

Dose Range
Trial-dependent (3.2 – 19.2 nmol/kg)
Route
SubQ
Frequency
Trial-dependent

§ 04   Evidence

Evidence & research

Clinical

Dhillon Dhillo Lab (Imperial) has run multiple Phase 2 studies.

FDA Status

Investigational. Not FDA-approved.

§ 06   News

In the news

8 articles from the last 12 months · updates hourly

§ 07   Sourcing

Sourcing & supply

Regulatory status

Restricted from compounding

Placed on the FDA's 503A Category 2 list and cannot be lawfully compounded in the US. No brand pharmacy alternative exists. US buyers encounter only research-use-only (RUO) channels, which the FDA's Intended Use Doctrine treats as unapproved drug sales.

Research-use-only · 1

Research-use-only

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§ 09   Safety

Safety & side effects

Side effects

  • 01Mild GI effects
  • 02Limited long-term data

Contraindications

None specified.

§ 10   References

Selected references

  1. 01

    Jayasena JCEM 2009

    PMID: 19820030

  2. 02

    Abbara — IVF triggering

    PMID: 26098212

  3. 03

    HSDD trial

    NCT02692456

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This site is for educational and research purposes only. It does not constitute medical advice. Always consult a qualified healthcare provider before using any peptide or supplement.