NDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1964
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
COSMEGEN (dactinomycin) by Recordati is synthesis. Approved for gestational trophoblastic tumor, choriocarcinoma. First approved in 1964.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COSMEGEN (dactinomycin) is a cytotoxic antibiotic that intercalates into DNA to inhibit RNA synthesis, approved in 1964 for gestational trophoblastic tumors and choriocarcinoma. It is administered as an intravenous injection and demonstrates broad cytotoxic activity across multiple cancer models. This is a legacy oncology product with a niche but critical indication in reproductive oncology.
LOE Approaching
Niche product approaching loss of exclusivity with likely modest team size focused on market maintenance and eventual transition planning.
Mechanism of Action
synthesis. The cytotoxic activity of dactinomycin has been demonstrated in animal models of different human cancers.
Indications (2)
Clinical Trials (1)
Addition of Ipilimumab (MDX-010) To Isolated Limb Infusion (ILI) With Standard Melphalan and Dactinomycin In The Treatment of Advanced Unresectable Melanoma of The Extremity
Started Feb 2011
26 enrolled
Melanoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.