CYTOTEC

LOE Approaching

misoprostol

NDAORALTABLETPriority Review
Approved
Dec 1988
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
12

Mechanism of Action

CLINICAL PHARMACOLOGY Pharmacokinetics Misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. The alpha side chain undergoes beta oxidation and the beta…

Pharmacologic Class:

Prostaglandin E1 Analog

Clinical Trials (5)

NCT07121634N/AActive Not Recruiting

Cervical Ripening With Misoprostol vs Isosorbide Mononitrate ; A Parallel -Arm Randomized Controlled Trial

Started Jan 2024
NCT05370976Phase 2Terminated

Efficacy and Safety of Cytotect®CP, Hyperimmune Anti-CMV IVIg as CMV Prophylaxis in Patients Developing Acute Grade II-IV GVHD After Allogeneic Hematopoietic Cell Transplantation.

Started Sep 2022
NCT02242214N/ACompleted

REgistry of MisOprostol 200 µg Vaginal dElivery System

Started Sep 2014
106 enrolled
Induction of Labour
NCT01283022Phase 2Completed

Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study)

Started May 2011
24 enrolled
Cervical RipeningInduction of Labor
NCT01127581Phase 3Completed

Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery

Started Sep 2010
1,358 enrolled
Reducing Time to Vaginal DeliveryCervical RipeningInduction of Labor