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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.

Guides & tools

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.