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Proellex
At a glance
| Generic name | Proellex |
|---|---|
| Also known as | CDB-4124, Telapristone acetate, telepristone acetate, telapristone acetate |
| Sponsor | Repros Therapeutics Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | discontinued |
Approved indications
Common side effects
Key clinical trials
- A Phase III, Three-Arm, Parallel Design, Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in the Treatment of Premenopausal Wo (Phase 3)
- An Open-Label Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids (Phase 2)
- Intra-mammary Distribution of Transdermal Telapristone Versus Oral Telapristone: A Randomized Window Trial in Women Undergoing Mastectomy (Phase 2)
- A Multi-Center, Placebo Controlled, Safety and Efficacy Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Anemic, Pre-Menopausal Women With Symptomatic Uterine Fibroids Re (Phase 3)
- Presurgical Phase IIB Trial of Oral CDB-4124 vs. Placebo in Women With Stage I-II Primary Breast Cancer (Phase 2)
- A Safety and Pharmacokinetic Study of 100 mg, 150 mg and 200 mg of Proellex® Taken for Seven Days by Healthy Adult Female Subjects (Phase 1)
- A Multicenter, Open-Label, Safety And Efficacy, Two Year Extension Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Pre-Menopausal Women With Symptomatic Leiomyomata Who (Phase 2)
- A Phase 2, Multi-Center, Five-Arm, Parallel Design, Randomized, Single-Blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in t (Phase 2)
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:
- Proellex CI brief — competitive landscape report
- Proellex updates RSS · CI watch RSS
- Repros Therapeutics Inc. portfolio CI