DACTINOMYCIN · Hikma
Dactinomycin is a cytotoxic actinomycin indicated for the treatment of adult and pediatric patients with Wilms tumor, rhabdomyosarcoma, Ewing sarcoma, and metastatic nonseminomatous testicular cancer, typically as part of a multi-phase, combination chemotherapy regimen. It is also indicated for post-menarchal patients with gestational trophoblastic neoplasia (as a single agent or in combination) and for adult patients with locally recurrent or locoregional solid malignancies as a component of palliative or adjunctive regional perfusion.
How DACTINOMYCIN Works
Dactinomycin exerts its cytotoxic effect by binding to DNA, which inhibits RNA synthesis and subsequently prevents the growth and proliferation of cancer cells.
Details
- Status
- Discontinued
- First Approved
- 1964-12-10
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DACTINOMYCIN Approval History
What DACTINOMYCIN Treats
6 indicationsDACTINOMYCIN is approved for 6 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Wilms Tumor
- Rhabdomyosarcoma
- Ewing Sarcoma
- Testicular Cancer
- Gestational Trophoblastic Neoplasia
- Solid Malignancies
DACTINOMYCIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in DACTINOMYCIN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DACTINOMYCIN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DACTINOMYCIN
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06401330 | AREN2231 NCI-2024-03424, AREN2231 | Ph 3 | recruiting | A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT) |
| NCT06647953 | ARAR2331 NCI-2024-08232, ARAR2331 | Ph 3 | recruiting | 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 |
| NCT04994132 | ARST2031 NCI-2021-06711, ARST2031 | Ph 3 | active not recruiting | A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma |
| NCT05304585 | ARST2032 NCI-2022-01012, ARST2032 | Ph 3 | recruiting | Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma |
| NCT02567435 results posted | NCI-2015-01644 NCI-2015-01644, ARST1431 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma |
| NCT01871766 | RMS13 NCI-2013-00913 | Ph 2 | active not recruiting | Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy |
| NCT07466316 | ARST2531 NCI-2026-00319, ARST2531 | Ph 3 | not yet recruiting | 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) |
| NCT06023641 | RMS2021 NCI-2024-00701 | Ph 2 | recruiting | Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease |
| NCT00945009 results posted | AREN0534 NCI-2011-01953, CDR0000649716 | Ph 3 | completed | Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor |
| NCT01535053 results posted | GOG-0275 NCI-2012-00250, CDR0000725211 | Ph 3 | completed | Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia |
| NCT01014767 results posted | CPT-SIOP-2009 | Ph 3 | terminated | Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors |
| NCT01055314 results posted | NCI-2011-02005 NCI-2011-02005, COG-ARST08P1 | Ph 2 | completed | Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma |
| NCT01531244 | 11-X335 | Ph 1, Ph 2 | withdrawn | Isolated Limb Infusion Chemotherapy With Targeted Gene Therapy for Advanced, Unresectable Extremity Melanoma |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DACTINOMYCIN FDA Label Details
Indications & Usage
Dactinomycin for Injection is an actinomycin indicated for the treatment of: adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. post-menarchal patients with gestational trophoblastic...
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Full clinical data, patents, trials, and competitive landscape for dactinomycin.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.