ObsEva (OBSEF) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Linzagolix | Healthy Participants, Hepatic Impairment | Phase I | Completed | Safety and Pharmacokinetics Study of Linzagolix in Female Subjects With Normal and Impaired Hepatic Function | May 22, 2019 | ― |
| Linzagolix | Healthy Participants, Renal Impairment | Phase I | Completed | Safety and Pharmacokinetics of Linzagolix in Female Subjects With Normal and Impaired Renal Function | May 20, 2019 | ― |
| Nolasiban | Infertility | Phase III | Completed | Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF | Nov 28, 2018 | ― |
| Atosiban, Obe022 | Preterm Labor | Phase II | Unknown | PoC Study of OBE022 in Threatened Preterm Labour | Nov 30, 2017 | ― |
| Nolasiban 900Mg | Infertility | Phase III | Completed | Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI | Mar 06, 2017 | ― |
| Obe2109, Add-Back | Uterine Fibroids, Heavy Menstrual Bleeding | Phase III | Completed | Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids | Feb 17, 2017 | ― |
| Obe2109, Add-Back | Uterine Fibroids, Heavy Menstrual Bleeding | Phase III | Completed | Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids | Feb 17, 2017 | ― |
| Obe2109 | Endometriosis | Phase II | Completed | A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis | May 03, 2016 | ― |
| Obe001 | Preterm Labor | Phase II | Terminated | A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth | Dec 22, 2014 | ― |
| Obe001 Dose 1, Obe001 Dose 2, Obe001 Dose 3 | Infertility | Phase II | Completed | OBE001 Phase 2 Dose-finding Study Versus Placebo in Women Undergoing Embryo Transfer in the Context of IVF-ICSI | Nov 19, 2014 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Linzagolix | Phase I | Healthy Participants, Hepatic Impairment | Completed | Safety and Pharmacokinetics Study of Linzagolix in Female Subjects With Normal and Impaired Hepatic Function | May 22, 2019 | ― |
| Linzagolix | Phase I | Healthy Participants, Renal Impairment | Completed | Safety and Pharmacokinetics of Linzagolix in Female Subjects With Normal and Impaired Renal Function | May 20, 2019 | ― |
| Nolasiban | Phase III | Infertility | Completed | Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF | Nov 28, 2018 | ― |
| Atosiban, Obe022 | Phase II | Preterm Labor | Unknown | PoC Study of OBE022 in Threatened Preterm Labour | Nov 30, 2017 | ― |
| Nolasiban 900Mg | Phase III | Infertility | Completed | Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI | Mar 06, 2017 | ― |
| Obe2109, Add-Back | Phase III | Uterine Fibroids, Heavy Menstrual Bleeding | Completed | Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids | Feb 17, 2017 | ― |
| Obe2109, Add-Back | Phase III | Uterine Fibroids, Heavy Menstrual Bleeding | Completed | Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids | Feb 17, 2017 | ― |
| Obe2109 | Phase II | Endometriosis | Completed | A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis | May 03, 2016 | ― |
| Obe001 | Phase II | Preterm Labor | Terminated | A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth | Dec 22, 2014 | ― |
| Obe001 Dose 1, Obe001 Dose 2, Obe001 Dose 3 | Phase II | Infertility | Completed | OBE001 Phase 2 Dose-finding Study Versus Placebo in Women Undergoing Embryo Transfer in the Context of IVF-ICSI | Nov 19, 2014 | ― |
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Obseva Sa (OBSEF) have in its pipeline
ObsEva OBSEF is currently developing the following drugs: Linzagolix, Nolasiban, Atosiban, Obe022, Nolasiban 900Mg, Obe2109, Add-Back, Obe2109, Obe001, Obe001 Dose 1, Obe001 Dose 2, Obe001 Dose 3. These drug candidates are in various stages of clinical development as the company works toward FDA approval.