Atosiban

Also known as: Tractocile

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 54 of 578 publications on PubMed
Registered clinical trials 23 3 active
Adverse event reports 830 823 classified as serious
  • Atosiban is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 578 publications mentioning it, including 54 randomized controlled trials and 172 animal-only studies.
  • ClinicalTrials.gov lists 23 registered studies testing it (3 active).
  • FDA's adverse event system (FAERS) holds 830 reports mentioning it; 823 classified as serious. Reports do not prove causation.

Research topics

  • Vasotocin 72
  • Oxytocin 52
  • Receptors, Oxytocin 38
  • Tocolytic Agents 38
  • Obstetric Labor, Premature 22
  • Pregnancy Rate 21
  • Premature Birth 21
  • Embryo Transfer 20
  • Tocolysis 15
  • Embryo Implantation 13

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 578
  • Human (MeSH) 332
  • Animal only 172
  • Clinical trials 70
  • Randomized controlled trials 54
  • Systematic reviews & meta-analyses 35
  • Case reports 23
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
23
Active
3
With posted results
2

Conditions studied

  • Premature Birth 2
  • Repeated Implantation Failure 2
  • Obstetric Labour, Premature 2
  • Infertility 1
  • Healthy Adult Male 1
  • Healhty 1
  • Endometriosis 1
  • Infertility, Female 1
  • Recurrent Implantation Failure 1
  • Preterm Labor 1
  • Cervical Cerclage 1
  • Preterm Birth 1
Study Status Phase Start
Atosiban in Women With Previous Implantation Failure and Abnormal Uterine Contractions
NCT07185230 Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Recruiting N/A December 6, 2025
The Effect of Oral Oxytocin and Atosiban on Top-down Attention ( OTAtosiban )
NCT07140237 University of Electronic Science and Technology of China
Recruiting Early phase 1 Sep 2025
The Effect of Oral Oxytocin and Atosiban on Social Attention
NCT07093060 University of Electronic Science and Technology of China
Recruiting Early phase 1 June 9, 2025
The Effect of Selective Oxytocin Receptor Inhibitors on Endometriosis-related Pain
NCT05382143 Radboud University Medical Center
Unknown status Phase 2 February 1, 2022
Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer
NCT03904745 Bezmialem Vakif University
Unknown status N/A December 21, 2020
Role of Atosiban in Recurrent Implantation Failure
NCT04118959 Al Baraka Fertility Hospital
Unknown status — October 10, 2019
PoC Study of OBE022 in Threatened Preterm Labour
NCT03369262 ObsEva SA
Unknown status Phase 2 January 10, 2018
Perioperative Use of Atosiban for Ultrasound-indicated Cerclage to Reduce Spontaneous Preterm Birth(sPTB)
NCT06537778 Children's Hospital of Chongqing Medical University
Completed N/A January 3, 2018
Atosiban Versus Placebo in the Treatment of Late Threatened Pre-term Birth
NCT05693688 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Completed Phase 4 December 1, 2017
In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline
NCT04468568 University of Sao Paulo General Hospital
Completed — October 1, 2017
Show 13 more studies
Study Status Phase Start
A Randomized Double Blind Comparison of Atosiban in Patients With RIF Undergoing IVF Treatment
NCT02893722 Shanghai First Maternity and Infant Hospital
Unknown status Phase 1 Jan 2017
Tocolytic Therapy for Preterm Labor in Multiple Gestation
NCT02725736 Tel-Aviv Sourasky Medical Center
Unknown status Phase 3 Mar 2016
Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
NCT02292784 GlaxoSmithKline Results posted
Completed Phase 3 June 1, 2015
A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour
NCT02292771 GlaxoSmithKline Results posted
Terminated Phase 3 March 16, 2015
Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth
NCT03570294 Polish Mother Memorial Hospital Research Institute
Completed N/A February 1, 2014
Oxytocin Antagonist in Patients With Repeated Failure of Implantation
NCT01673399 AZ Jan Palfijn Gent
Completed Phase 4 Feb 2012
Use of Atosiban in in Vitro Fertilization (IVF) Treatment
NCT01501214 The University of Hong Kong
Completed Phase 4 Dec 2011
Nifedipine Treatment in Preterm Labor
NCT01314859 Hospital Clinico Universitario de Santiago
Withdrawn Phase 3 Jul 2011
Atosiban Improves Implantation and Pregnancy Rates in Patients With Repeated Implantation Failure
NCT01493440 An Sinh Hospital
Completed N/A Mar 2011
Influence of Tocolytical Medications on Hemodynamics (Central and Peripheral) and Vascular Function in a Pilot Study to Determine the Design of the Final Study and the Final Study Itself
NCT00679705 University Hospital, Ghent
Completed Phase 1 May 2008
Nifedipine Compared to Atosiban for Treating Preterm Labor
NCT00599898 Raed Salim
Completed Phase 4 Jan 2008
Effect of Oxytocin and Vasopressin Antagonists on Uterine Contractions
NCT00587327 Ferring Pharmaceuticals
Completed Phase 2 Nov 2007
Single Versus Combination Therapy in Acute Tocolysis
NCT01429545 Tawam Hospital
Completed Phase 2 Apr 2007

All 23 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
830
Serious
823
With death outcome
25

Most reported reactions

  • Maternal exposure during pregnancy 335
  • Premature baby 328
  • Foetal exposure during pregnancy 278
  • Premature delivery 248
  • Product use in unapproved indication 179
  • Delivery 123
  • Normal labour 123
  • Exposure during pregnancy 72
  • Low birth weight baby 65
  • Drug exposure during pregnancy 47
  • Foetal growth restriction 44
  • Acute pulmonary oedema 37

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.