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 20h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COSMEGEN (dactinomycin) is a classic cytotoxic antibiotic that intercalates into DNA to inhibit RNA synthesis, demonstrating activity across multiple human cancer models. Originally approved in 1964, it is administered by injection for oncology indications. The drug represents a foundational chemotherapy agent with a long clinical history.
LOE Approaching
Product lifecycle is in mature/LOE stage with minimal linked job openings, indicating small team size and limited commercial expansion.
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 exposure to legacy oncology portfolio management and niche market dynamics under Recordati sponsorship. Career growth is constrained by LOE lifecycle stage and minimal job market demand, making this suitable for specialists interested in rare disease or mature asset stewardship rather than rapid advancement.
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.