NDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1964
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
Priority Review
COSMEGEN (dactinomycin) by Recordati is synthesis. First approved in 1964.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COSMEGEN (dactinomycin) is a classic cytotoxic antibiotic that intercalates into DNA and inhibits RNA synthesis, with demonstrated efficacy across multiple human cancer models. It is administered via injection and used primarily in pediatric and adult cancers including Wilms tumor, rhabdomyosarcoma, and gestational trophoblastic disease. This 60-year-old drug represents a foundational chemotherapy agent in oncology.
LOE Approaching
Product approaching loss of exclusivity with low linked job volume signals a mature, specialty-focused team managing a legacy oncology asset with limited growth trajectory.
Mechanism of Action
synthesis. The cytotoxic activity of dactinomycin has been demonstrated in animal models of different human cancers.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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
Career Relevance
Working on COSMEGEN offers limited growth acceleration due to its mature, specialty-focused market position and approaching loss of exclusivity. Roles tend toward relationship management, clinical support, and regulatory maintenance rather than launch or innovation-driven activities.
Brand Manager
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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.