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Cosmegen (DACTINOMYCIN)
Dactinomycin binds DNA and inhibits RNA synthesis, demonstrating cytotoxic activity in cancer models.
Dactinomycin (Cosmegen), marketed by Recordati, is a well-established cytotoxic agent primarily indicated for the treatment of Wilms Tumor. Its key strength lies in its mechanism of action, binding DNA and inhibiting RNA synthesis, which effectively demonstrates cytotoxic activity in cancer models. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | DACTINOMYCIN |
|---|---|
| Sponsor | Recordati |
| Drug class | Actinomycin [EPC] |
| Target | DNA |
| Modality | Recombinant protein |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1964 |
Mechanism of action
Dactinomycin is a cytotoxic agent that works by binding to DNA, which prevents the synthesis of RNA. This inhibition of RNA synthesis leads to cell death, making it effective against various human cancers in animal models.
Approved indications
- Wilms Tumor
- Rhabdomyosarcoma
- Ewing Sarcoma
- Metastatic Nonseminomatous Testicular Cancer
- Gestational Trophoblastic Neoplasia
- Locally Recurrent or Locoregional Solid Malignancies
Common side effects
- Hepatic failure
- Sepsis
- Hepatitis
- Hepatomegaly
- Hepatic veno-occlusive disease
- Renal failure
- Renal impairment
- Disseminated intravascular coagulation
- Pneumonitis
- Pneumothorax
- Gastrointestinal ulceration
- Hepatotoxicity
Key clinical trials
- Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma (PHASE3)
- Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor (PHASE3)
- Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes (PHASE1)
- A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS) (PHASE3)
- A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT) (PHASE3)
- A Single-Arm Study on the Efficacy of Sequential Chemoradiotherapy Followed by Surgery in Adult Nasal and Paranasal Sinus Rhabdomyosarcoma
- Testing a Standardized Approach to Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma or the Addition of an Anti-cancer Drug, Topotecan, to the Usual Treatment for Types II and III Pleuropulmonary Blastoma (PHASE3)
- Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma (PHASE3)
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:
- Cosmegen CI brief — competitive landscape report
- Cosmegen updates RSS · CI watch RSS
- Recordati portfolio CI