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prolutex
prolutex is a Small molecule drug developed by El Shatby University Hospital for Obstetrics and Gynecology. It is currently in Phase 2 development.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | prolutex |
|---|---|
| Sponsor | El Shatby University Hospital for Obstetrics and Gynecology |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. (PHASE3)
- Trial Comparing Subcutaneous Natural Progesterone (Prolutex) vs. Cetrorelix Acetate for Luteinizing Hormone Surge Suppression in Freeze-All IVF Cycles. (PHASE4)
- Prolutex in Frozen Embryo Transfer Cycles At the Blastocyst Stage (PROGEX) (PHASE2)
- Impact of Corpus Luteum Presence or Absence in the Incidence of Preeclampsia After Frozen Embryo Transfer (NA)
- The Importance of Embryo Transfer Day Progesterone Value in Natural Cycle Frozen Embryo Transfers and the Evaluation of the Effect of Rescue Therapy on Pregnancy Outcomes in Patients With Low Progesterone Levels (NA)
- The Rescue of Hormonal Replacement Frozen Embryo Transfer Cycle With Low Serum Progesterone. (PHASE2, PHASE3)
- Comparison of the Effect of Subcutaneous Progesterone and Vaginal Progesterone for Luteal Phase Support (NA)
- Effects of E2, P4 and LH Levels on the Day of Transfer and Endometrial Cavity Thickness on Implantation Success in Patients With Frozen-thawed Embryo Transfer Cycle (NA)
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:
- prolutex CI brief — competitive landscape report
- prolutex updates RSS · CI watch RSS
- El Shatby University Hospital for Obstetrics and Gynecology portfolio CI
Frequently asked questions about prolutex
What is prolutex?
Who makes prolutex?
What development phase is prolutex in?
Related
- Manufacturer: El Shatby University Hospital for Obstetrics and Gynecology — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing