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Progesterone Vaginal Suppository
Progesterone Vaginal Suppository is a Small molecule drug developed by Assiut University. It is currently in Phase 1 development.
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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 | Progesterone Vaginal Suppository |
|---|---|
| Sponsor | Assiut University |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Vaginal discharge
- Lower abdominal or pelvic pressure
- Vaginal soreness/discomfort
- Lower abdominal or pelvic pain
- Vaginal itching
- Headache
- Vaginal odor
- Incontinence or change in urinary frequency
- Vulvovaginal mycotic infection
- Bacterial vaginosis
- Vulvovaginitis
- Vaginal burning
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:
- Progesterone Vaginal Suppository CI brief — competitive landscape report
- Progesterone Vaginal Suppository updates RSS · CI watch RSS
- Assiut University portfolio CI
Frequently asked questions about Progesterone Vaginal Suppository
What is Progesterone Vaginal Suppository?
Who makes Progesterone Vaginal Suppository?
What development phase is Progesterone Vaginal Suppository in?
What are the side effects of Progesterone Vaginal Suppository?
Related
- Manufacturer: Assiut University — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing