MedPath

Atosiban

Generic Name
Atosiban
Brand Names
Tractocile, Atosiban SUN
Drug Type
Small Molecule
Chemical Formula
C43H67N11O12S2
CAS Number
90779-69-4
Unique Ingredient Identifier
081D12SI0Z

Overview

Atosiban is an inhibitor of the hormones oxytocin and vasopressin. It is used intravenously to halt premature labor. Although initial studies suggested it could be used as a nasal spray and hence would not require hospital admission, it is not used in that form. Atobisan was developed by the Swedish company Ferring Pharmaceuticals. It was first reported in the literature in 1985. Atosiban is licensed in proprietary and generic forms for the delay of imminent pre-term birth in pregnant adult women.

Indication

Atosiban is indicated for use in delaying imminent pre-term birth in pregnant adult women with:

Associated Conditions

  • Premature Births

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/08/05
Not Applicable
Completed
Children's Hospital of Chongqing Medical University
2023/01/23
Phase 4
Completed
2022/05/19
Phase 2
UNKNOWN
2020/07/13
N/A
Completed
2019/04/05
Not Applicable
UNKNOWN
2018/06/26
Not Applicable
Completed
Polish Mother Memorial Hospital Research Institute
2017/12/11
Phase 2
UNKNOWN
2016/09/08
Phase 1
UNKNOWN
2016/04/01
Phase 3
UNKNOWN
2014/11/17
Phase 3
Terminated

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
No HSA approvals found for this drug.

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

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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