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Actinex (MASOPROCOL)
Actinex (MASOPROCOL) is a small molecule drug that targets aromatase, a key enzyme involved in the production of estrogen. It was originally developed and is currently owned by a pharmaceutical company. Actinex is FDA-approved for the treatment of actinic keratosis, a skin condition caused by prolonged sun exposure. The drug is off-patent, meaning it is no longer protected by patents, and there are no generic manufacturers. As a result, its commercial status is uncertain.
At a glance
| Generic name | MASOPROCOL |
|---|---|
| Drug class | masoprocol |
| Target | Aromatase |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1992 |
Approved indications
- Actinic keratosis
Common side effects
Key clinical trials
- Terameprocol in Treating Patients With Recurrent High Grade Glioma (PHASE1)
- Tetra-O-Methyl Nordihydroguaiaretic Acid in Treating Patients With Recurrent High-Grade Glioma (PHASE1,PHASE2)
- A Pilot Study of EM-1421 for the Treatment of Cervical Intraepithelial Neoplasia (PHASE1,PHASE2)
- Study of Intralesional Injection of M4N in Patients With Refractory Malignant Tumors of the Head and Neck (PHASE1)
- A Phase 1 Continuous Intravenous Infusion Study of Terameprocol (EM-1421) in Subjects With Refractory Solid Tumors (PHASE1)
- Phase 1 Study of Terameprocol (EM-1421) in Patients With Leukemia (PHASE1)
- Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non Metastatic Recurrent Prostate Cancer (PHASE2)
- Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer (PHASE1)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Actinex CI brief — competitive landscape report
- Actinex updates RSS · CI watch RSS