PeptideTrace
Research CompoundOxytocin Analogue (Long-Acting)Sexual Health & Hormonal

Carbetocin (Pabal, Duratocin)

B

Evidence Grade B — Strong clinical evidence. 410 published studies, 248 human. 36 registered clinical trials.

36 trials410 studiesUSEUCA

Medically reviewed by a licensed medical professional

Overview

Carbetocin is a long-acting version of oxytocin that has been studied to prevent dangerous bleeding after childbirth. It is registered in over 80 countries outside the US but has never received FDA approval. A heat-stable formulation — one that does not need refrigeration — was added to the WHO Essential Medicines List, addressing a critical need in tropical and low-resource settings where standard oxytocin degrades in the heat.

Also Known As

Carbetocin is also known by these brand and alternate names:

Research Activity

410studies
Human 248
Animal 73
In-vitro 17
Reviews 75

410 published studies: 248 human, 73 animal, 17 in-vitro, 75 reviews

Regulatory Status

US
Not approved by FDA(FDA)
EU
Not authorised by EMA(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USNot applicable (not approved)
EUNot applicable (not authorised)
CAPrescription drug

Summary

Carbetocin has not been approved by the FDA. It is registered in over 80 countries for prevention of uterine atony and excessive bleeding after caesarean delivery. A heat-stable formulation was added to the WHO Essential Medicines List in 2019.

The CHAMPION trial (WHO, 2018; over 29,000 women) compared a heat-stable carbetocin formulation to oxytocin for preventing postpartum haemorrhage after vaginal delivery, and found it to be non-inferior. The heat-stable formulation addresses a significant limitation of oxytocin, which degrades in warm climates without refrigeration — a major concern in low-resource settings where postpartum haemorrhage causes the most deaths. Its regulatory status varies by jurisdiction.

Mechanism of Action

Carbetocin activates the same oxytocin receptor as natural oxytocin, producing uterine contractions. Its molecular structure includes a modification that prevents the body from breaking it down as quickly as natural oxytocin, extending its duration of action to approximately 40 minutes compared to oxytocin's 3–17 minutes. This longer action means a single dose may be sufficient where oxytocin would require a continuous infusion.

Research Summary

The WHO-sponsored CHAMPION trial (over 29,000 women) found heat-stable carbetocin non-inferior to oxytocin for preventing postpartum haemorrhage after vaginal delivery. This matters because standard oxytocin requires refrigeration, which is often unreliable in the regions where postpartum haemorrhage is the leading cause of maternal death. The US market has not been pursued, likely because reliable cold-chain oxytocin is ubiquitous in US healthcare facilities. A development programme for Prader-Willi syndrome (a genetic condition) failed, closing the most advanced pathway for major-market development. Carbetocin's global health significance rests on the heat-stable formulation for resource-limited settings.

Clinical Trials

PeptideTrace tracks 36 registered clinical trials for Carbetocin sourced from ClinicalTrials.gov.

NCT07187544N/ARecruiting

Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery

Samuel Lunenfeld Research Institute, Mount Sinai HospitalEndpoint: Uterine Tone 10 minutesCompletion: 2026-12-01
NCT06946589Phase IVNot Yet Recruiting

Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section

Jordan LeitchEndpoint: Patient reported symptomsCompletion: 2027-09-01
NCT06776926N/ACompleted

Timing of Carbetocin Administration in Postpartum Hemorrhage

Mehmet Mete KırlangıçEndpoint: Carbetosin effectCompletion: 2025-02-28
NCT06420297Phase IIIEnrolling by Invitation

OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

ACADIA Pharmaceuticals Inc.Endpoint: Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), withdrawals due to adverse events (AEs), potentially clinically important changes in other safety assessments, device incidents or device malfunctionsCompletion: 2029-06-01
NCT06173531Phase IIIActive, Not Recruiting

Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

ACADIA Pharmaceuticals Inc.Endpoint: Change from Baseline at Week 12 in caregiver-rated Hyperphagia Questionnaire for Clinical Trials (HQ-CT) scoreCompletion: 2025-11-01
View all 36 trials on ClinicalTrials.gov →

Regulatory Timeline

2020
Regulatory

Health Canada Market Authorisation

Scientific Detail

Overview (Scientific)

Carbetocin (1-deamino-1-monocarba oxytocin) is a long-acting synthetic oxytocin analogue in which the disulfide bridge is replaced with a thioether linkage, preventing enzymatic reduction and extending the half-life to approximately 40 minutes (versus 3–5 minutes for oxytocin). It has never been approved by the FDA.

Mechanism of Action (Scientific)

Carbetocin activates the oxytocin receptor (OXTR) via the same Gq/PLC/IP3 signaling pathway as oxytocin, producing uterine smooth muscle contraction. The thioether modification provides extended receptor occupancy and a longer duration of uterotonic action compared to oxytocin, enabling single-dose administration for PPH prevention rather than the continuous infusion required with oxytocin.

Summary (Scientific)

Carbetocin has never been FDA-approved in the United States. It is registered in over 80 countries for prevention of postpartum hemorrhage following cesarean delivery. A heat-stable formulation was added to the WHO Essential Medicines List in 2019, addressing the cold-chain limitation of oxytocin in low-resource settings. The WHO CHAMPION trial (~30,000 women across 10 countries) demonstrated carbetocin was non-inferior to oxytocin for PPH prevention. Acadia Pharmaceuticals pursued intranasal carbetocin for Prader-Willi syndrome (hyperphagia), but the Phase 3 COMPASS PWS trial failed its primary endpoint in September 2025, and Acadia announced discontinuation of the program.

The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.

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Related Research

This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.