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vaginal progesterone suppositories
vaginal progesterone suppositories is a Small molecule drug developed by Toronto Centre for Advanced Reproductive Technology. It is currently in Phase 1 development. Also known as: Prometrium.
Vaginal progesterone suppositories are used to treat conditions such as frozen embryo transfer, infertility, and premature labor. They work by acting as a progesterone receptor agonist, stimulating the progesterone receptor to exert their effects.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | vaginal progesterone suppositories |
|---|---|
| Also known as | Prometrium |
| Sponsor | Toronto Centre for Advanced Reproductive Technology |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency (PHASE1)
- Comparison Between Natural Progesterone and Vaginal Pessary for the Prevention of Spontaneous Preterm Birth (PHASE4)
- A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix (PHASE3)
- Comparison of Two Vaginal Progesterone Forms in Frozen Embryo Transfer
- Comparison of Two Protocols in Frozen Embryo Transfer (NA)
- LATe Cerclage in High-risk Pregnancies (LATCH) (NA)
- Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration. (PHASE1)
- Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support (PHASE4)
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:
- vaginal progesterone suppositories CI brief — competitive landscape report
- vaginal progesterone suppositories updates RSS · CI watch RSS
- Toronto Centre for Advanced Reproductive Technology portfolio CI
Frequently asked questions about vaginal progesterone suppositories
What is vaginal progesterone suppositories?
Who makes vaginal progesterone suppositories?
Is vaginal progesterone suppositories also known as anything else?
What development phase is vaginal progesterone suppositories in?
Related
- Manufacturer: Toronto Centre for Advanced Reproductive Technology — full pipeline
- Also known as: Prometrium
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing