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Progesterone Effervescent Vaginal Tablets
Progesterone Effervescent Vaginal Tablets is a Progestin Small molecule drug developed by University of Alberta. It is currently in Phase 3 development for Luteal phase support in assisted reproductive technology (ART), Early pregnancy maintenance / luteal phase deficiency. Also known as: Endometrin 100 mg twice daily.
Progesterone is a naturally occurring steroid hormone that binds to progesterone receptors to support luteal phase function and maintain pregnancy.
Progesterone Effervescent Vaginal Tablets are used to treat fertility issues, including embryo implantation and frozen embryo transfer, as well as preterm labor. They work by supplementing progesterone, a hormone involved in the menstrual cycle and pregnancy, as indicated by their use in ClinicalTrials.gov for various conditions.
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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 | Progesterone Effervescent Vaginal Tablets |
|---|---|
| Also known as | Endometrin 100 mg twice daily |
| Sponsor | University of Alberta |
| Drug class | Progestin |
| Target | Progesterone receptor (PR) |
| Modality | Small molecule |
| Therapeutic area | Reproductive Health / Obstetrics |
| Phase | Phase 3 |
Mechanism of action
Progesterone acts as a ligand for intracellular progesterone receptors (PR-A and PR-B), modulating gene transcription to promote endometrial secretion, reduce uterine contractility, and support early pregnancy maintenance. The effervescent vaginal tablet formulation delivers progesterone directly to the reproductive tract, providing local and systemic hormone replacement or supplementation during the luteal phase or early pregnancy.
Approved indications
- Luteal phase support in assisted reproductive technology (ART)
- Early pregnancy maintenance / luteal phase deficiency
Common side effects
- Vaginal irritation or discharge
- Headache
- Breast tenderness
- Abdominal discomfort
Key clinical trials
- Rescue Progesterone Supplementation During Frozen Embryo Transfer (PHASE2)
- Adjunctive Vaginal Progesterone in Management of Preterm Labor (PHASE4)
- Luteal Phase Progesterone in IUI and Gonadotropin Cycles (PHASE3)
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:
- Progesterone Effervescent Vaginal Tablets CI brief — competitive landscape report
- Progesterone Effervescent Vaginal Tablets updates RSS · CI watch RSS
- University of Alberta portfolio CI
Frequently asked questions about Progesterone Effervescent Vaginal Tablets
What is Progesterone Effervescent Vaginal Tablets?
How does Progesterone Effervescent Vaginal Tablets work?
What is Progesterone Effervescent Vaginal Tablets used for?
Who makes Progesterone Effervescent Vaginal Tablets?
Is Progesterone Effervescent Vaginal Tablets also known as anything else?
What drug class is Progesterone Effervescent Vaginal Tablets in?
What development phase is Progesterone Effervescent Vaginal Tablets in?
What are the side effects of Progesterone Effervescent Vaginal Tablets?
What does Progesterone Effervescent Vaginal Tablets target?
Related
- Drug class: All Progestin drugs
- Target: All drugs targeting Progesterone receptor (PR)
- Manufacturer: University of Alberta — full pipeline
- Therapeutic area: All drugs in Reproductive Health / Obstetrics
- Indication: Drugs for Luteal phase support in assisted reproductive technology (ART)
- Indication: Drugs for Early pregnancy maintenance / luteal phase deficiency
- Also known as: Endometrin 100 mg twice daily
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing