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Progesteron TID
Progesteron TID is a Progestin / Progesterone receptor agonist Small molecule drug developed by University Hospital, Ghent. It is currently in Phase 3 development for Recurrent miscarriage prevention, Preterm birth prevention.
Progesterone acts as a ligand for progesterone receptors, modulating gene transcription and hormonal signaling pathways involved in reproductive and metabolic processes.
Progesterone acts as a ligand for progesterone receptors, modulating gene transcription and hormonal signaling pathways involved in reproductive and metabolic processes. Used for Recurrent miscarriage prevention, Preterm birth prevention.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Progesteron TID |
|---|---|
| Sponsor | University Hospital, Ghent |
| Drug class | Progestin / Progesterone receptor agonist |
| Target | Progesterone receptor (PR) |
| Modality | Small molecule |
| Therapeutic area | Obstetrics/Gynecology |
| Phase | Phase 3 |
Mechanism of action
Progesterone binds to intracellular progesterone receptors (PR-A and PR-B), which translocate to the nucleus and regulate transcription of target genes. This mechanism is fundamental to maintaining pregnancy, regulating the menstrual cycle, and modulating immune and metabolic functions. The TID (three times daily) dosing regimen suggests use of a micronized or bioavailable formulation to achieve therapeutic levels.
Approved indications
- Recurrent miscarriage prevention
- Preterm birth prevention
Common side effects
- Drowsiness or sedation
- Headache
- Breast tenderness
- Mood changes
- Gastrointestinal upset
Key clinical trials
- Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone (PHASE3)
- Efficacy and Safety of Gushen Antai Pill on Ongoing Pregnancy Rate in Women With Normal Ovarian Reserve Undergoing IVF-ET (PHASE4)
- Rescue Progesterone Supplementation During Frozen Embryo Transfer (PHASE2)
- Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert (PHASE1)
- Natural Versus Artificial Cycle for Frozen-Thawed Embryo Transfer (PHASE4)
- Descriptive Analysis of Serum Immunological Markers During an Euploid Frozen Embryo Transfer in a Natural Cycle.
- Progesterone-modified Natural Cycle for FET (PHASE3)
- Endometrial Transcript Profile with Progesterone After Post-ovulatory Mifepristone (EARLY_PHASE1)
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:
- Progesteron TID CI brief — competitive landscape report
- Progesteron TID updates RSS · CI watch RSS
- University Hospital, Ghent portfolio CI
Frequently asked questions about Progesteron TID
What is Progesteron TID?
How does Progesteron TID work?
What is Progesteron TID used for?
Who makes Progesteron TID?
What drug class is Progesteron TID in?
What development phase is Progesteron TID in?
What are the side effects of Progesteron TID?
What does Progesteron TID target?
Related
- Drug class: All Progestin / Progesterone receptor agonist drugs
- Target: All drugs targeting Progesterone receptor (PR)
- Manufacturer: University Hospital, Ghent — full pipeline
- Therapeutic area: All drugs in Obstetrics/Gynecology
- Indication: Drugs for Recurrent miscarriage prevention
- Indication: Drugs for Preterm birth prevention
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing