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
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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
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Nolasiban
Infertility
Phase III
Completed
Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF
Nov 28, 2018
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Atosiban, Obe022
Preterm Labor
Phase II
Unknown
PoC Study of OBE022 in Threatened Preterm Labour
Nov 30, 2017
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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
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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
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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
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Obe2109
Endometriosis
Phase II
Completed
A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis
May 03, 2016
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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
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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
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 (OBSEF) have in its pipeline
OBSEF is currently developing the following drugs: Linzagolix, Linzagolix, Nolasiban. These drug candidates are in various stages of clinical development as the company works toward FDA approval.