Reproductive & sexual health
Carbetocin
A long-acting oxytocin analogue approved in many countries — but not the US — to prevent uterine atony after delivery.
Also known as: Duratocin, Pabal
Evidence passport
Last reviewed 2026-08-23
- Evidence level
- L4Strong human
- Confidence
- Moderate confidence
- Human efficacy
- 70/100
- Human safety
- 70/100
- Regulatory status
- Approved — specific region(s)
- Development
- Approved
- Routes
- IVIM
- Evidence base
- Includes human data
- Furthest stage
- Approved
- Source curation
- Sources fully curated
- Clinical maturity
- Approved regionally; long clinical use
Overview
Clinical maturity: Approved regionally; long clinical use
Routes & formulations
Studied / approved routes
Given as a single injection (IV or IM depending on the national label) in the peripartum setting.
Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.
Peptide lifecycle
Discovery
Preclinical
Phase I
Phase II
Phase III
Approved
Approved through national procedures in many markets; no US development programme is established in the curated record.
What it is
A modified oxytocin analogue engineered for longer action, used where a sustained uterotonic effect is wanted after delivery.
What people claim
- Prevents uterine atony and excessive bleeding after caesarean delivery
What the evidence actually says
Randomised trials support its uterotonic role in the settings covered by national labels. It is a useful illustration that approval is regional: widely used in Europe and elsewhere, absent from the US market.
Human evidence
- Randomised controlled trials versus oxytocin in caesarean and postpartum settings.
- National regulatory assessments across multiple markets.
Preclinical evidence
- Oxytocin-analogue receptor pharmacology with extended duration of action.
Animal and cell findings are Level 1–2 evidence.
Mechanism and pathways
- Oxytocin-receptor agonism with slower degradation produces a prolonged uterotonic effect.
Safety and unknowns
- Adverse-effect profile is broadly similar to oxytocin within labelled use.
- Not interchangeable with unregulated oxytocin-like research products.
Cancer relevance
No concern identified
Regulatory status
Authorised in numerous countries through national approvals, including across EU member states via national procedures, for prevention of uterine atony and postpartum haemorrhage in specified obstetric settings. Not FDA-approved; EMA material describes nationally authorised products rather than a centralised EU approval.
Evidence grade
Solid controlled human trials, though not yet definitive or fully replicated.
What would change our rating?
- Not applicable at this evidence tier.
References and sources
- Regulatory / labelEMA PSUSA: carbetocin — list of nationally authorised medicinal products
- Regulatory / labelEMA CHMP monthly report, May 2006 (carbetocin opinion)
Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.
Evidence change history
No recorded changes yet. Baseline position set on 2026-08-23.