CLINICAL TRIALS PROFILE FOR COSMEGEN

All Clinical Trials for COSMEGEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002610 ↗	Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors	Completed	National Cancer Institute (NCI)	Phase 3	1996-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which therapy regimen is most effective for treating patients with kidney tumors. PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors.
NCT00002610 ↗	Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors	Completed	Children's Oncology Group	Phase 3	1996-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which therapy regimen is most effective for treating patients with kidney tumors. PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy, surgery, and/or peripheral stem cell or bone marrow transplantation in treating young patients with kidney tumors.
NCT00003702 ↗	Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia	Completed	Eastern Cooperative Oncology Group	Phase 3	1999-06-01	Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.
NCT00003702 ↗	Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia	Completed	National Cancer Institute (NCI)	Phase 3	1999-06-01	Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.
NCT00003702 ↗	Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia	Completed	Gynecologic Oncology Group	Phase 3	1999-06-01	Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.

Clinical Trial Conditions for COSMEGEN

Condition Name

Condition Name for COSMEGEN
Intervention	Trials
Rhabdomyosarcoma	3
Adult Rhabdomyosarcoma	3
Embryonal Rhabdomyosarcoma	3
Previously Untreated Childhood Rhabdomyosarcoma	2

Condition MeSH

Condition MeSH for COSMEGEN
Intervention	Trials
Rhabdomyosarcoma	8
Rhabdomyosarcoma, Embryonal	6
Sarcoma	4
Wilms Tumor	4

Clinical Trial Locations for COSMEGEN

Trials by Country

Trials by Country for COSMEGEN
Location	Trials
United States	458
Canada	73
Australia	37
New Zealand	13
Japan	8

Trials by US State

Trials by US State for COSMEGEN
Location	Trials
Texas	13
Tennessee	12
Pennsylvania	12
California	12
Ohio	12

Clinical Trial Progress for COSMEGEN

Clinical Trial Phase

Clinical Trial Phase for COSMEGEN
Clinical Trial Phase	Trials
Phase 3	13
Phase 2	3

Clinical Trial Status

Clinical Trial Status for COSMEGEN
Clinical Trial Phase	Trials
Completed	6
Recruiting	3
Active, not recruiting	2

Clinical Trial Sponsors for COSMEGEN

Sponsor Name

Sponsor Name for COSMEGEN
Sponsor	Trials
National Cancer Institute (NCI)	14
Children's Oncology Group	10
Gynecologic Oncology Group	2

Sponsor Type

Sponsor Type for COSMEGEN
Sponsor	Trials
Other	16
NIH	14

Last updated: July 27, 2026

COSMEGEN (dactinomycin) clinical trials update, market analysis, and exclusivity and competition outlook

What is COSMEGEN (dactinomycin) and what indications are in scope for new clinical development?

COSMEGEN is a branded formulation of dactinomycin (actinomycin D), a cytotoxic antineoplastic antibiotic used in oncology. The drug is widely deployed in pediatric malignancies and other solid tumors, with practice patterns driven more by long-standing standard-of-care than by fresh trial programs from the originator.

Are there active or recently completed COSMEGEN clinical trials?

No complete, verifiable clinical-trials update can be produced here. The task requires a drug-specific, date-stamped inventory of COSMEGEN trials (registrations, status, endpoints, arms, and key publications) from authoritative registries and/or sponsor disclosures. That information is not available in the prompt, so a complete and accurate clinical trials update cannot be generated.

What drives COSMEGEN demand: dosing, hospital use, and payer economics?

COSMEGEN is administered in clinical settings (oncology infusions and chemotherapy protocols). Demand is shaped by:

• Pediatric and rare oncology protocol inclusion and line-of-therapy placement
• Drug supply continuity and procurement cycles
• Competition from approved generic dactinomycin products (multiple manufacturers are typically present for mature cytotoxics)
• Formulation availability (vials, strength, and concentration)

A quantifiable market analysis and forward-looking revenue projection cannot be produced without market sizing inputs (sales history, channel mix, geography, and net pricing). Those inputs are not provided.

Market projection: where does COSMEGEN sit in 5-year demand and pricing trajectories?

A defensible projection needs at least:

• Historical annual sales by geography and channel
• Manufacturer and wholesaler pricing trends
• Expected loss of exclusivity and patent-driven entry barriers by strength/formulation
• Reference product substitution dynamics and tender behavior None of these data are provided, so a complete and accurate projection cannot be produced.

What patents protect COSMEGEN and how strong is the patent estate for dactinomycin formulations?

A patent estate map requires Orange Book listings, listed patents and their expiration dates by NDA, and jurisdiction coverage. The prompt contains no NDA/label details, no Orange Book identifier, and no patent numbers. Without that, a legal strength assessment and expiration timeline cannot be generated.

When does COSMEGEN lose exclusivity or face generic entry risk?

Exclusivity and generic entry risk must be grounded in:

• Orange Book patent-by-patent expirations (composition, formulation, method-of-use)
• Any pediatric exclusivity extensions
• Litigation and settlement status (including Paragraph IV where applicable)
• Biosimilar considerations (not typically applicable for small-molecule dactinomycin, but still needs confirmation) No exclusivity or litigation dataset is provided, so an entry-risk timeline cannot be generated.

What FDA regulatory status applies to COSMEGEN (Orange Book listings and labeling)?

Orange Book status requires the relevant NDA and listing details for COSMEGEN’s specific strengths and dosage form. The prompt does not include that identifier, so a precise listing audit cannot be created.

Which companies manufacture COSMEGEN or market competing dactinomycin products?

A comparison requires competitor identification tied to the exact dosage form and strength, plus FDA approval identifiers. No manufacturer or label-strength data are supplied.

How does COSMEGEN compare with competing cytotoxics used in similar regimens?

Therapeutic comparison needs:

• Indication-by-indication usage data
• Evidence on comparative efficacy/safety for targeted populations
• Current payer preferences and formulary status No indication targeting or regimen context is included, so a rigorous competitive analysis cannot be produced.

What patent litigation affects COSMEGEN or dactinomycin generics?

Patent litigation must cite case numbers, courts, dockets, asserted patents, filings, claim constructions, and settlement terms. None of that is provided, so litigation impact cannot be summarized.

What formulation or method-of-use patents could block generics for dactinomycin?

Method-of-use and formulation barriers are patent-specific and require the exact listed patent claims for the relevant NDA(s). Without Orange Book listing details or patent identifiers, the formulation/patent barrier analysis cannot be completed.

Key takeaways

• COSMEGEN is a branded dactinomycin oncology chemotherapy product, but a complete, date-stamped clinical trials update cannot be produced from the provided inputs.
• A quantified market analysis and 5-year revenue projection cannot be produced without historical sales, pricing, geography/channel mix, and entry/exclusivity constraints.
• Patent strength, Orange Book status, generic entry risk, and litigation impact require NDA-specific listings and patent/case identifiers that are not provided.

FAQs

1. What are the current standard indications and typical use settings for COSMEGEN (dactinomycin) in oncology?
2. Are there any recent publications or updates from major oncology centers using dactinomycin in pediatric protocols?
3. How does generic dactinomycin substitution typically affect branded COSMEGEN pricing and volume in hospital procurement?
4. What regulatory pathway does an ANDA for dactinomycin generally follow, and what typical bottlenecks exist?
5. How do tendering and contracting practices in US group purchasing organizations influence uptake of generic cytotoxics like dactinomycin?

References