MedPath

Carbetocin

Generic Name
Carbetocin
Brand Names
Duratocin
Drug Type
Small Molecule
Chemical Formula
C45H69N11O12S
CAS Number
37025-55-1
Unique Ingredient Identifier
88TWF8015Y

Overview

Carbetocin is a drug used to control postpartum hemorrhage, bleeding after giving birth. It is an analogue of oxytocin, and its action is similar to that of oxytocin -- it causes contraction of the uterus.

Indication

Used to control postpartum hemorrhage and bleeding after giving birth.

Associated Conditions

  • Postpartum Haemorrhage (PPH)
  • Uterine Atony

Research Report

Published: Aug 5, 2025

Carbetocin: A Comprehensive Pharmacological and Clinical Monograph

Introduction

Carbetocin is a long-acting, synthetic nonapeptide analogue of the endogenous human hormone oxytocin, engineered to possess enhanced stability and a prolonged duration of action.[1] It has established a prominent position in modern obstetric practice as a critical uterotonic agent, a class of drugs that stimulates contraction of the myometrium.[1] The principal clinical indication for Carbetocin is the prevention of postpartum hemorrhage (PPH), a life-threatening complication of childbirth characterized by excessive bleeding.[5] Its use is particularly well-established following Cesarean section and is increasingly supported for the prevention of PPH after vaginal delivery.[8]

The primary pharmacological distinction and clinical advantage of Carbetocin over oxytocin, the conventional first-line uterotonic, lies in its significantly longer biological half-life and duration of action.[10] This superior pharmacokinetic profile, a direct result of specific structural modifications to the oxytocin peptide, allows for effective uterine tone to be achieved and maintained with a single bolus injection. This contrasts sharply with the short half-life of oxytocin, which often necessitates a prolonged intravenous infusion to prevent uterine atony, the most common cause of PPH.[10]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/27
Phase 4
Not yet recruiting
Jordan Leitch
2025/04/16
Not Applicable
Recruiting
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
2024/11/18
N/A
Completed
2024/05/20
Phase 3
ENROLLING_BY_INVITATION
2024/03/27
Not Applicable
Recruiting
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
2024/02/29
Not Applicable
Recruiting
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
2024/01/22
Phase 1
Completed
2023/12/15
Phase 3
Active, not recruiting
2023/12/07
N/A
Completed
Ministry of Health and Population, Egypt
2023/08/14
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
DURATOCIN RTS SOLUTION FOR INJECTION 100 MCG/ML
SIN15173P
INJECTION, SOLUTION
100 mcg/ml
2/8/2017

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
DURATOCIN
Ferring Inc
02231593
Solution - Intravenous
100 MCG / ML
8/1/1999
DURATOCIN
Ferring Inc
02496526
Solution - Intramuscular ,  Intravenous
100 MCG / ML
8/5/2020
CARBETOCIN INJECTION
Juno Pharmaceuticals Corp.
02489244
Solution - Intravenous
100 MCG / ML
1/21/2020

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
CARBETOCINA GP-PHARM 100 MICROGRAMOS SOLUCION INYECTABLE EN JERINGA PRECARGADA
Gp Pharm S.A.
79228
SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Uso Hospitalario
Commercialized
DURATOBAL 100 microgramos/ml SOLUCION INYECTABLE
Ferring S.A.
68550
SOLUCIÓN INYECTABLE
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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