Data updated: May 26, 2026
COSMEGEN (dactinomycin)
Trial Activity: Expansion 9 active trials
Oncology
Approved 1964-12-10
Development Insights
Children's Oncology Group conducting 6 trials (46%)
40 indications explored (Broad Platform)
→ rhabdomyosarcoma (4 trials)
→ embryonal rhabdomyosarcoma (3 trials)
→ alveolar rhabdomyosarcoma (2 trials)
2
Indications
--
Phase 3 Trials
1
Priority Reviews
61
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1964-12-10
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
COSMEGEN Approval History
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Original
New Indication
New Form
Label Update
22 FDA actions from 1964 to 2018 · 1 indication expansions
Apr 2015 SUPPL Priority
Mfg · Manufacturing (CMC)
Feb 2001 SUPPL Priority
Mfg
Jan 2001 SUPPL
Label
Jun 2000 SUPPL
Label
Feb 1999 SUPPL Priority
Mfg
May 1998 SUPPL Priority
Mfg
Mar 1998 SUPPL Priority
Mfg
Jun 1997 SUPPL Priority
Mfg
Feb 1997 SUPPL
Label
Feb 1997 SUPPL
Label
Feb 1996 SUPPL Priority
Mfg
Mar 1988 SUPPL
Label
Dec 1964 ORIGINAL Priority
New Drug
What COSMEGEN Treats
2 FDA approvalsOriginally approved for its first indication in 1964 . Covers 2 distinct patient populations.
- Other (2)
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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 | active not recruiting | 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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
COSMEGEN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment