Atosiban has been investigated in numerous clinical trials spanning Early Phase 1 through Phase 4 studies. These evaluations, supported by both academic institutions such as Radboud University Medical Center and pharmaceutical sponsors like GlaxoSmithKline, encompass recruitment statuses ranging from recruiting and completed to terminated. Research primarily focuses on obstetric and gynecological conditions, including premature labor in single and multiple gestations, female infertility, repeated implantation failure, and endometriosis-associated pain. For instance, trials such as NCT02725736 assess tocolytic efficacy in preterm gestations, whereas studies like NCT05382143 and NCT02893722 explore its utility in endometriosis and implantation failure.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07185230 | RECRUITING | Infertility |
Northwest Women's and Children's Hospital, Xi'an, Shaanxi |
2025-12-06 | |
| NCT07140237 | RECRUITING | Healthy Adult Male |
University of Electronic Science and Technology of China |
2025-09 | EARLY_PHASE1 |
| NCT07093060 | RECRUITING | Healhty |
University of Electronic Science and Technology of China |
2025-06-09 | EARLY_PHASE1 |
| NCT05693688 | COMPLETED | Preterm Birth |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
2017-12-01 | PHASE4 |
| NCT06537778 | COMPLETED | Cervical Cerclage; Premature Birth |
Children's Hospital of Chongqing Medical University |
2018-01-03 | |
| NCT05382143 | UNKNOWN | Endometriosis |
Radboud University Medical Center |
2022-02-01 | PHASE2 |
| NCT03904745 | UNKNOWN | Infertility, Female |
Bezmialem Vakif University |
2020-12-21 | |
| NCT03369262 | UNKNOWN | Preterm Labor |
ObsEva SA |
2018-01-10 | PHASE2 |
| NCT02292784 | COMPLETED | Obstetric Labour, Premature |
GlaxoSmithKline |
2015-06-01 | PHASE3 |
| NCT03570294 | COMPLETED | Premature Birth |
Polish Mother Memorial Hospital Research Institute |
2014-02-01 | |
| NCT02725736 | UNKNOWN | Labor Preterm Multiple |
Tel-Aviv Sourasky Medical Center |
2016-03 | PHASE3 |
| NCT02893722 | UNKNOWN | Repeated Implantation Failure |
Shanghai First Maternity and Infant Hospital |
2017-01 | PHASE1 |
| NCT02292771 | TERMINATED | Obstetric Labour, Premature |
GlaxoSmithKline |
2015-03-16 | PHASE3 |
| NCT01673399 | COMPLETED | Implantation Failure |
AZ Jan Palfijn Gent |
2012-02 | PHASE4 |
| NCT01501214 | COMPLETED | Subfertility |
The University of Hong Kong |
2011-12 | PHASE4 |
| NCT01314859 | WITHDRAWN | Threatened Preterm Labor |
Hospital Clinico Universitario de Santiago |
2011-07 | PHASE3 |
| NCT00599898 | COMPLETED | Labor, Premature |
Raed Salim |
2008-01 | PHASE4 |
| NCT01493440 | COMPLETED | Repeated Implantation Failure |
An Sinh Hospital |
2011-03 | |
| NCT01429545 | COMPLETED | Preterm Labour |
Tawam Hospital |
2007-04 | PHASE2 |
| NCT00679705 | COMPLETED | Healthy |
University Hospital, Ghent |
2008-05 | PHASE1 |
| NCT00587327 | COMPLETED | In Vitro Fertilisation (IVF) Treatment |
Ferring Pharmaceuticals |
2007-11 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2025-12-09)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).