Who makes PROMETRIUM® 400 mg?

PROMETRIUM® 400 mg is developed by Solvay Pharmaceuticals.

What development phase is PROMETRIUM® 400 mg in?

PROMETRIUM® 400 mg is FDA-approved (marketed).

Last reviewed 2026-04-20 · How we verify

PROMETRIUM® 400 mg

Solvay Pharmaceuticals · FDA-approved active Small molecule Quality 5/100

At a glance

Generic name	PROMETRIUM® 400 mg
Sponsor	Solvay Pharmaceuticals
Modality	Small molecule
Phase	FDA-approved

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone (PHASE3)
Artificial Cycle With or Without GnRH Agonist Pre-treatment for Frozen Embryo Transfer in Adenomyosis Patients (NA)
Exogenous Progesterone as Ovulation Trigger (PHASE4)
Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix (NA)
Impact of Corpus Luteum Presence or Absence in the Incidence of Preeclampsia After Frozen Embryo Transfer (NA)
Pessary Versus Cerclage With or Without Progesterone in Twins (NA)
Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM (PHASE4)
SHorter Treatment of Replacement Therapy for Frozen Embryo Transfer (FET) (NA)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

PROMETRIUM® 400 mg CI brief — competitive landscape report
PROMETRIUM® 400 mg updates RSS · CI watch RSS
Solvay Pharmaceuticals portfolio CI