FDA Approved Sexual & Reproductive Health

Oxytocin

also known as: Pitocin, Syntocinon, OXT

An endogenous nine-amino-acid hormone with roles in labor, lactation, and social-affiliative behavior; also explored off-label for social/anxiety research.

A cyclic nine-amino-acid peptide synthesized in the paraventricular and supraoptic nuclei of the hypothalamus that acts peripherally on uterine/mammary tissue and centrally on social cognition circuits.

Mechanism of action

Agonist at the oxytocin receptor (OXTR), a Gq-coupled GPCR. Peripheral effects include uterine smooth muscle contraction and milk ejection. Central effects — studied via intranasal administration in research — include modulation of amygdala activity, social salience, trust, and pair-bonding behavior. Central effects are inconsistently replicated.

Primary uses

  • Labor induction (FDA-approved)
  • Postpartum hemorrhage prevention (FDA-approved)
  • Autism spectrum disorder (investigational)
  • Social anxiety / PTSD (research)

Typical dosing

varies by indication varies (IV (labor) / intranasal (research))

Research intranasal dosing often 24 IU single-dose. Community use carries significant cardiovascular and water-intoxication risks.

Regulatory status

FDA-approved as Pitocin (injectable) for labor induction and postpartum hemorrhage. Intranasal preparations are not FDA-approved in the US but available in some regions for lactation support.

References

  1. [fda-pi] Pitocin (oxytocin) Prescribing Information. Par Pharmaceutical.
  2. [review] Leng G, Ludwig M. "Intranasal Oxytocin: Myths and Delusions." Biol Psychiatry, 2016;79:243-250.
  3. [review] MacDonald E, et al. "A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research." Psychoneuroendocrinology, 2011;36:1114-1126.

Related peptides

Carbetocin

Ferring's Pabal / Duratocin — a long-acting oxytocin analog used for prevention of postpartum hemorrhage after cesarean delivery. Approved in Canada, the UK, the EU, and (as heat-stable carbetocin) prequalified by WHO for low-resource settings. Not FDA-approved: the FDA declined to approve the product in 2006 and it has not been re-filed.

Atosiban

Ferring's Tractocile — an oxytocin-receptor antagonist used in Europe and elsewhere as a tocolytic for short-term suppression of preterm labor between 24 and 33 weeks' gestation. Approved by the EMA in 2000; the FDA declined to approve atosiban in 1998 citing a higher fetal/infant death rate in the <26-week subgroup of the pivotal trial.

PT-141

An FDA-approved melanocortin agonist for acquired, generalized hypoactive sexual desire disorder in premenopausal women.
Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.