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Progenta
Progenta is a Small molecule drug developed by Repros Therapeutics Inc.. It is currently in Phase 1 development. Also known as: CDB-4124, Telapristone acetate.
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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 | Progenta |
|---|---|
| Also known as | CDB-4124, Telapristone acetate |
| Sponsor | Repros Therapeutics Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy (PHASE2)
- Oral CDB-4124 vs. Placebo in Stage I-II Primary Breast Cancer (PHASE2)
- A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata (PHASE1, PHASE2)
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:
- Progenta CI brief — competitive landscape report
- Progenta updates RSS · CI watch RSS
- Repros Therapeutics Inc. portfolio CI
Frequently asked questions about Progenta
What is Progenta?
Who makes Progenta?
Is Progenta also known as anything else?
What development phase is Progenta in?
Related
- Manufacturer: Repros Therapeutics Inc. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: CDB-4124, Telapristone acetate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing