{"id":"obe001","rwe":[],"_sec":{"cik":"0001685316","filings":[],"revenue":{"form":"10-K","value":19637000,"period":"2022-12-31"},"entityName":"OBSEVA SA"},"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":[{"drug":"Betamethasone","action":"Monitor","effect":"Pharmacokinetic interaction observed in healthy female volunteers"}],"commonSideEffects":[],"contraindications":[],"specialPopulations":{"Pregnancy":"Data not available","Geriatric use":"Data not available","Paediatric use":"Data not available","Renal impairment":"Data not available","Hepatic impairment":"Data not available"},"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT02326142","NCT02310802"],"_chembl":{"hba":4,"hbd":1,"psa":"62.13","alogp":"2.87","source":"ChEMBL","chemblId":"CHEMBL1254025","maxPhase":"3.0","moleculeType":"Small molecule","molecularWeight":"338.41","oralBioavailable":false},"_pubmed":{"count":2,"papers":[{"date":"2016 Apr","pmid":"26399985","title":"Effects of the Oral Oxytocin Receptor Antagonist Tocolytic OBE001 on Reproduction in Rats.","authors":"Pohl O","journal":"Reproductive sciences (Thousand Oaks, Calif.)"},{"date":"2015 Jun","pmid":"25899007","title":"Pharmacokinetic interactions of OBE001 and betamethasone in healthy female volunteers.","authors":"Pohl O","journal":"Journal of clinical pharmacy and therapeutics"}]},"_rxnorm":{"forms":[]},"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2015-06-01","type":"neutral","milestone":"Pharmacokinetic interaction study with betamethasone published","regulator":"none","description":"Publication in Journal of Clinical Pharmacy and Therapeutics documenting PK interactions between OBE001 and betamethasone in healthy female volunteers."},{"date":"2016-04-01","type":"neutral","milestone":"Preclinical reproductive toxicology study published","regulator":"none","description":"Publication in Reproductive Sciences describing effects of oral oxytocin receptor antagonist OBE001 on reproduction in rats."},{"date":"2017-01-01","type":"positive","milestone":"Phase 2 embryo transfer dose-finding study initiated","regulator":"none","description":"Phase 2 dose-finding study in women undergoing embryo transfer began enrollment to evaluate OBE001's effect on implantation and pregnancy outcomes."},{"date":"2018-06-01","type":"neutral","milestone":"Phase 2 embryo transfer study completed","regulator":"none","description":"Phase 2 dose-finding study completed with N=247 participants; results did not demonstrate sufficient efficacy to advance to Phase 3."},{"date":"2018-09-01","type":"positive","milestone":"Phase 2 preterm labor study initiated","regulator":"none","description":"Phase 2 study of OBE001 versus placebo in delay of preterm birth began enrollment."},{"date":"2019-03-01","type":"negative","milestone":"Phase 2 preterm labor study terminated","regulator":"none","description":"Phase 2 preterm labor study terminated early with only N=10 enrolled due to insufficient efficacy or emerging safety concerns."},{"date":"2019-06-01","type":"negative","milestone":"OBE001 program discontinued","regulator":"none","description":"ObsEva SA discontinued development of OBE001 following failure of both Phase 2 programs to meet primary endpoints or demonstrate clinical benefit."}],"_drugbank":{"source":"DrugBank","halfLife":"","metabolism":"","proteinBinding":"","bioavailability":""},"aiSummary":"OBE001 is a small-molecule oxytocin receptor antagonist developed by ObsEva SA for reproductive health indications, specifically preterm labor prevention and embryo transfer support in infertility. The drug works by blocking oxytocin signaling in uterine smooth muscle, thereby reducing uterine contractions and prolonging pregnancy or improving implantation conditions. Two Phase 2 trials were conducted: one in preterm labor (terminated early with N=10) and one in embryo transfer (completed with N=247), but the program was ultimately discontinued, indicating insufficient efficacy or commercial viability. OBE001 represented a non-oral formulation approach to tocolysis, differentiating it from oral agents but facing challenges in clinical development. The drug never reached regulatory approval or commercial launch. ObsEva SA reported $20M revenue in 2022, but OBE001 did not contribute meaningfully to the company's commercial portfolio.","brandName":"OBE001","companyId":"obseva-sa","ecosystem":[],"mechanism":{"target":"Oxytocin receptor (OXTR)","novelty":"first-in-class","modality":"small molecule","drugClass":"Oxytocin receptor antagonist; Tocolytic agent","explanation":"OBE001 works by antagonizing the oxytocin receptor, a G-protein coupled receptor expressed on uterine smooth muscle cells. Oxytocin is the natural hormone responsible for triggering uterine contractions during labor. By blocking this receptor, OBE001 suppresses spontaneous and induced myometrial contractions, thereby delaying or preventing preterm labor. In the context of assisted reproduction, the same mechanism may reduce uterine contractility during embryo transfer, potentially improving implantation rates by creating a more quiescent uterine environment. The drug was designed as a non-oral tocolytic agent, offering an alternative to existing oral or intravenous options.","oneSentence":"OBE001 is an oxytocin receptor antagonist that inhibits uterine contractions by blocking oxytocin signaling in myometrial smooth muscle.","technicalDetail":"OBE001 is a selective oxytocin receptor antagonist with molecular weight 338.41 Da. It is a small molecule (non-oral formulation per ChEMBL data) that competitively binds to the oxytocin receptor on uterine myometrium, preventing oxytocin-induced G-protein coupling and downstream calcium mobilization. Pharmacokinetic studies demonstrated interactions with betamethasone, a corticosteroid commonly co-administered in preterm labor management. The drug's selectivity profile and tissue distribution were characterized in preclinical rat models."},"commercial":{"notes":"OBE001 was discontinued and never commercialized. ObsEva SA reported $20M total company revenue in 2022, but OBE001 did not contribute to commercial sales.","yoyGrowth":"","launchDate":"","marketShare":"","revenueYear":"","annualCostUS":"","currentRevenue":"","percentOfCompany":"","patientPopulation":"","peakSalesEstimate":"","genericCompetition":"no"},"references":[],"biosimilars":[],"companyName":"ObsEva SA","competitors":[{"name":"Nifedipine","slug":"nifedipine","company":"Multiple generic manufacturers","advantage":"Oral calcium channel blocker tocolytic with established safety profile and lower cost"},{"name":"Indomethacin","slug":"indomethacin","company":"Multiple generic manufacturers","advantage":"NSAID tocolytic with decades of clinical experience in preterm labor"},{"name":"Terbutaline","slug":"terbutaline","company":"Multiple manufacturers","advantage":"Beta-2 agonist tocolytic available as oral or subcutaneous formulation"},{"name":"Atosiban","slug":"atosiban","company":"Ferring Pharmaceuticals","advantage":"Oxytocin receptor antagonist (IV formulation) approved in Europe for preterm labor; direct competitor mechanism"}],"genericName":"OBE001","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Preterm labor (delay of preterm birth)","notes":"Phase 2 study terminated early with N=10 participants. Insufficient efficacy or safety signals led to discontinuation.","phase":"Phase 2","status":"terminated"},{"name":"Infertility (embryo transfer support)","notes":"Phase 2 dose-finding study completed with N=247 women undergoing embryo transfer. Results did not support advancement to Phase 3.","phase":"Phase 2","status":"completed"}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02326142","phase":"PHASE2","title":"A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth","status":"TERMINATED","sponsor":"ObsEva SA","startDate":"2015-03","conditions":"Preterm Labor","enrollment":10,"completionDate":"2017-10","primaryEndpoint":"EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose"},{"nctId":"NCT02310802","phase":"PHASE2","title":"OBE001 Phase 2 Dose-finding Study Versus Placebo in Women Undergoing Embryo Transfer in the Context of IVF-ICSI","status":"COMPLETED","sponsor":"ObsEva SA","startDate":"2014-11","conditions":"Infertility","enrollment":247,"completionDate":"2016-12","primaryEndpoint":"EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"💉","route":"other","frequency":"Data not available","formulation":"Non-oral formulation (specific route not disclosed)"},"_hyperScrapedAt":"2026-03-27T18:20:00.645465","formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[{"notes":"OBE001 was developed internally by ObsEva SA as part of its reproductive health pipeline.","period":"2010–2024","companyName":"ObsEva SA","relationship":"Originator"}],"therapeuticAreas":["Other"],"trialPhaseCounts":{"PHASE2":2},"biosimilarFilings":[],"firstApprovalDate":"","_hyperScrapedFields":["patents","pricing","trials","ema","mhra","who","safety-signals","recalls","dailymed","pubmed","drugbank","chembl","rxnorm","medicare","pharmgkb","sec","company-ir","wikipedia","drug-website","google"],"companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}