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Proellex
Proellex is a Small molecule drug developed by Repros Therapeutics Inc.. It is currently in discontinued development. Also known as: CDB-4124, Telapristone acetate, telepristone acetate, telapristone acetate.
Proellex, also known as telapristone acetate, is a small molecule that modulates the progesterone receptor, classified as a progesterone receptor modulator. It is being studied in clinical trials for the treatment of uterine fibroids, endometriosis, and is also being evaluated in an extension study for safety and efficacy.
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
Frequently asked questions about Proellex
What is Proellex?
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Is Proellex also known as anything else?
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Related
- Manufacturer: Repros Therapeutics Inc. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: CDB-4124, Telapristone acetate, telepristone acetate, telapristone acetate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing