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Drug

Progesterone

Approved · FDA
ClassProgesterone receptor agonistEmerging researchLate-stage developmentCooling momentum
Also known as (S)-Progesterone, 17alpha-Progesterone, Bijuva, Corpus Luteum Hormone+21 more

(S)-Progesterone, 17alpha-Progesterone, Bijuva, Corpus Luteum Hormone, Crinone, Eazi-Breed CIDR, Endometrin, Gelbkörperhormon, Lutogynon, Prochieve, Progest, Progesterone (micronized), Progesterone Micronized, Progesterone-IBSA, Prometrium, Synovex C, Synovex S, Progesteron, Progesterona, Progestérone, (S)-4-Pregnene-3,20-dione, (S)-Pregn-4-en-3,20-dione, Pregn-4-ene-3,20-dione, Progesteronum, delta(4)-Pregnene-3,20-dione.

12
Research papers
15
Active clinical trials
Progesterone receptor
Primary target
12
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency

Clinical trial2026-07-09Results expected Q4 2031 · ClinicalTrials.gov

PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)

Clinical trial2026-06-03Results posted · ClinicalTrials.gov

Metabolic control of luteinizing hormone-responsive ovarian steroidogenesis.

Research2024-11-29The Journal of biological chemistry

Recall (Class II): PROGESTERONE

Regulatory2024-07-26FDA

Diagnostic and therapeutic use of oral micronized progesterone in endocrinology.

Research2024-04-23Reviews in endocrine & metabolic disorders

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Progesterone
Aliases & brands
(S)-Progesterone17alpha-ProgesteroneBijuvaCorpus Luteum HormoneCrinoneEazi-Breed CIDREndometrinGelbkörperhormonLutogynonProchieveProgestProgesterone (micronized)Progesterone MicronizedProgesterone-IBSAPrometriumSynovex CSynovex SProgesteronProgesteronaProgestérone(S)-4-Pregnene-3,20-dione(S)-Pregn-4-en-3,20-dionePregn-4-ene-3,20-dioneProgesteronumdelta(4)-Pregnene-3,20-dione
RxNorm CUI
8727
ChEMBL ID
CHEMBL103
ATC codes
G03DA04
UNII
4G7DS2Q64Y
Primary mechanism
Progesterone receptor agonist
Regulatory jurisdictions
fda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

AGONISTProgesterone receptor agonist

Regulatory timeline

12 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-06-21
Latest approval
2026-07-16
Authorities
FDA
Total events
12
fdaU.S. Food and Drug Administration· 12 events
2026-07-16Supplemental approval
Supplemental approval: PROGESTERONE (NDA022057)
Evidence ↗
2026-07-15Label change
Label change: PROGESTERONE (NDA022057)
Evidence ↗
2024-07-26RecallSafety
Recall (Class II): PROGESTERONE
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

173 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
173
registered trials across all phases
LATEST COMPLETION 2025
15
Active studies
14
Recruiting
126
Late-stage (III+)
107
Completed
51
Discontinued
PHASE DISTRIBUTIONn = 173
Early Phase 15Phase 113Phase 1 / 25Phase 224Phase 2 / 36Phase 332Phase 450Phase N / A38

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

12 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
19902025
Most influential
Recent papers
Major research themes8
Progesterone4Menstrual Cycle2Anorexia Nervosa1C-Reactive Protein1Cardiovascular System1Contraceptives, Oral1Diet1Estradiol1
Journals, researchers & institutions
Top journals
  • Advanced science (Weinheim, Baden-Wurttemberg, Germany)1
  • American journal of obstetrics and gynecology1
  • BMC endocrine disorders1
  • European journal of endocrinology1
  • Journal of affective disorders1
  • Journal of applied physiology (Bethesda, Md. : 1985)1
Leading researchers
  • Conde-Agudelo A2
  • Creasy GW2
  • Fusey S2
  • Hassan SS2
  • Romero R2
  • Soma-Pillay P2
  • Akinbote A1
  • Alfirevic Z1
Leading institutions
free-text, unnormalised
  • Aarhus University Hospital1
  • Aretaieion Hospital1
  • Attikon General Hospital1
  • Centre for Immunobiology1
  • Centre for Neuroendocrinology and Department of Anatomy1
  • Chulalongkorn University and Excellence Center in Diabetes1

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 6 of the same disease areas as Progesterone in the shared literature.

6 shared diseases4 shared papers

Studied across 6 of the same disease areas as Progesterone in the shared literature.

6 shared diseases2 shared papers

Studied across 6 of the same disease areas as Progesterone in the shared literature.

6 shared diseases2 shared papers

Studied across 4 of the same disease areas as Progesterone in the shared literature.

4 shared diseases2 shared papers

Studied across 5 of the same disease areas as Progesterone in the shared literature.

5 shared diseases1 shared paper

Studied across 4 of the same disease areas as Progesterone in the shared literature.

4 shared diseases1 shared paper

Studied across 2 of the same disease areas as Progesterone in the shared literature.

2 shared diseases2 shared papers

Studied across 2 of the same disease areas as Progesterone in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.