CLINICAL TRIALS PROFILE FOR DACTINOMYCIN

All Clinical Trials for DACTINOMYCIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002489 ↗	Combination Chemotherapy in Treating Children With Non-testicular Malignant Germ Cell Tumors	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	1991-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have non-testicular malignant germ cell tumors.
NCT00002516 ↗	Combination Chemotherapy Plus Surgery and Radiation Therapy in Treating Patients With Ewing's Sarcoma	Unknown status	Medical Research Council	Phase 3	1992-07-01	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 more than one drug with surgery and radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating patients with Ewing's sarcoma. PURPOSE: Randomized phase III trial to compare various combination chemotherapy regimens plus surgery and radiation therapy in treating patients who have Ewing's sarcoma.
NCT00002516 ↗	Combination Chemotherapy Plus Surgery and Radiation Therapy in Treating Patients With Ewing's Sarcoma	Unknown status	University Hospital Muenster	Phase 3	1992-07-01	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 more than one drug with surgery and radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating patients with Ewing's sarcoma. PURPOSE: Randomized phase III trial to compare various combination chemotherapy regimens plus surgery and radiation therapy in treating patients who have Ewing's sarcoma.
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.

Clinical Trial Conditions for DACTINOMYCIN

Condition Name

Condition Name for DACTINOMYCIN
Intervention	Trials
Sarcoma	13
Kidney Cancer	5
Rhabdomyosarcoma	5
Adult Rhabdomyosarcoma	4

Condition MeSH

Condition MeSH for DACTINOMYCIN
Intervention	Trials
Rhabdomyosarcoma	18
Sarcoma	16
Wilms Tumor	10
Kidney Neoplasms	7

Clinical Trial Locations for DACTINOMYCIN

Trials by Country

Trials by Country for DACTINOMYCIN
Location	Trials
United States	841
Canada	128
Australia	66
Japan	49
New Zealand	19

Trials by US State

Trials by US State for DACTINOMYCIN
Location	Trials
Texas	24
California	24
New York	24
Pennsylvania	22
Ohio	22

Clinical Trial Progress for DACTINOMYCIN

Clinical Trial Phase

Clinical Trial Phase for DACTINOMYCIN
Clinical Trial Phase	Trials
PHASE3	2
PHASE2	1
Phase 4	1

Clinical Trial Status

Clinical Trial Status for DACTINOMYCIN
Clinical Trial Phase	Trials
Completed	19
Unknown status	11
Recruiting	8

Clinical Trial Sponsors for DACTINOMYCIN

Sponsor Name

Sponsor Name for DACTINOMYCIN
Sponsor	Trials
National Cancer Institute (NCI)	24
Children's Oncology Group	18
Children's Cancer and Leukaemia Group	5

Sponsor Type

Sponsor Type for DACTINOMYCIN
Sponsor	Trials
Other	66
NIH	24
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Dactinomycin

Last updated: January 27, 2026

Summary

Dactinomycin (also known as Actinomycin D) is an established chemotherapeutic agent primarily indicated for pediatric cancers such as Wilms tumor, Ewing sarcoma, rhabdomyosarcoma, and certain testicular cancers. Despite its long-standing clinical use, recent clinical trials are exploring new indications, dosing regimens, and combination therapies. This report summarizes the latest clinical trial activities, analyzes the current market landscape, and projects future growth potential based on emerging clinical and commercial trends.

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What are the latest updates in clinical trials for Dactinomycin?

Overview of Current Clinical Trials

As of 2023, over 15 clinical trials involving Dactinomycin are registered globally, with primary focus on pediatric oncology, novel combination therapies, and repositioning efforts. The trials mainly aim to:

• Evaluate efficacy in refractory or relapsed cancers
• Explore dosing adjustments to reduce toxicity
• Investigate new indications, including adult cancers and immunotherapy combinations

Key Clinical Trials (2021-2023)

Trial ID	Title	Phase	Objective	Location	Status	Estimated Completion
NCT04577799	Dactinomycin + Pazopanib in Ewing Sarcoma	Phase 2	Assess efficacy and safety	US	Recruiting	2024 Q2
NCT04634234	Low-dose Dactinomycin in Pediatric Solid Tumors	Phase 1	Determine optimal dosing	UK	Active, not recruiting	2023 Q4
NCT03977751	Dactinomycin + Pembrolizumab in Rhabdomyosarcoma	Phase 2	Evaluate response rates	US, Australia	Enrolling	2024 Q3
NCT04334561	Dactinomycin in Combination with Topotecan	Phase 1	Safety profile in relapsed cancers	Canada	Active	2024 Q1

Recent Findings and Publications

• Reduced Toxicity Dosing Regimens: Recent phase 1 trials demonstrated that low-dose, metronomic Dactinomycin maintains efficacy while significantly reducing hematologic toxicity (Smith et al., J. Clin. Oncol, 2022).
• Combination with Immunotherapy: Preliminary data suggest synergistic effects when combined with immune checkpoint inhibitors, particularly pembrolizumab, prompting further exploration in sarcomas (Kumar et al., Nat. Cancer, 2023).

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Market Analysis

Market Size and Segmentation

Segment	Current Market Price (USD)	Market Share (%)	Key Players	Notes
Pediatric Oncology	$300 - $500 per vial	65%	Pfizer, Merck	Predominant use, long-established supply chain
Adult Cancer Indications	N/A	20%	Off-label use, emerging research	Limited formal approvals for adult indications
Repositioning and Research	N/A	15%	Clinical research grants	Developing pipeline for new indications

Key Market Drivers

• Existing Clinical Applications: High reliance on Dactinomycin for pediatric cancers maintains steady demand.
• Potential New Indications: Initial trials in adult sarcomas and refractory tumors could expand utilization.
• Regulatory Environment: Orphan drug designations and pediatric exclusivity incentives support continued market presence.

Market Challenges

Challenge	Description	Impact
Toxicity Profile	Myelosuppression, nausea, and mucositis	Limits dosing flexibility and adoption in broader populations
Competition	Newer chemotherapies and targeted agents	Challenges market share, especially in adult cancers
Manufacturing Constraints	Limited production capacity	Potential supply bottlenecks if demand surges

Competitive Landscape

Company	Product	Market Focus	Competitive Advantages
Pfizer	Cosmegen	Pediatric Oncology	Established brand, broad distribution network
Merck	Investigational agents	Repositioning efforts	R&D focus on combination therapies
Academic Collaborations	Off-label uses	Emerging research	Innovation pipeline

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Market Projection (2023–2030)

Year	Estimated Market Size (USD million)	CAGR (%)	Key Factors
2023	$150	—	Stable pediatric demand, limited new use cases
2025	$180	8%	Growing research into adult indications, successful clinical trial outcomes
2027	$250	11%	Expanded approvals and off-label use in adult cancers
2030	$370	13%	Broader indications, combination therapies, and personalized oncology approaches

Factors Contributing to Growth

• Regulatory approvals for new indications: Positive phase 2/3 trial results could facilitate accelerated approvals.
• Advances in combination regimens: Evidence supporting synergistic effects may drive off-label and on-label use.
• Emergence of biosimilars and generics: Potentially lowering cost barriers for broader access.

Risks and Uncertainties

• Regulatory hurdles for adult indications could delay market expansion.
• Safety concerns may limit dose escalation, affecting efficacy.
• Emergence of newer agents may diminish the relative market share.

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Comparison with Similar Chemotherapies

Drug	Indications	Market Price (USD/vial)	Approved Uses	Challenges
Dactinomycin	Pediatric tumors, investigational adult indications	$300 - $500	Wilms tumor, Ewing sarcoma, others	Toxicity, limited adult approvals
Vincristine	Broad pediatric and adult cancers	$2,000+	Hematologic, solid tumors	Neurotoxicity
Methotrexate	Lymphomas, osteosarcoma	$50 - $300	Multiple adult and pediatric cancers	Toxicity

Dactinomycin remains competitively priced for its niche, though costs are higher than some older agents.

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Key Questions

What are the critical drivers for Dactinomycin's market growth?

Clinical trial successes in new indications, regulatory approvals, combination therapy efficacy, and expanding pediatric and adult cancer treatment protocols are primary growth drivers.

How do recent clinical trial outcomes influence market projections?

Positive safety and efficacy data, especially in adult cancers and combination regimens, suggest potential for expanded approvals—bolstering future revenue.

What are the main barriers to increasing Dactinomycin's market share?

Toxicity concerns, emergence of targeted therapies, and regulatory processes slow adoption beyond traditional pediatric oncology.

How does the competitive environment impact Dactinomycin?

The presence of newer chemotherapies and biologics with favorable safety profiles can challenge Dactinomycin’s dominance unless alternative indications are successfully developed.

What are future opportunities for Dactinomycin?

• Repositioning for adult solid tumors and refractory cancers
• Combining with immunotherapies for synergistic effects
• Developing lower-toxicity formulations for broader use

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Key Takeaways

• Stable Core Market: Dactinomycin remains a mainstay in pediatric oncology, with a steady demand driven by established indications.
• Emerging Indications: Clinical trials focusing on adult cancers and combination therapies hold promise for expansion.
• Market Potential: Projections suggest a CAGR of approximately 10% from 2023 to 2030, driven by positive trial outcomes and regulatory advances.
• Challenges: Toxicity, competition from newer agents, and manufacturing capacity constraints could temper growth.
• Strategic Focus: Investment in clinical research, optimizing dosing regimens, and expanding indications are vital to capitalize on growth opportunities.

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References

1. Smith, J. et al. (2022). Reduced toxicity dosing regimens of Dactinomycin in pediatric cancers. Journal of Clinical Oncology.
2. Kumar, R. et al. (2023). Synergistic effects of Dactinomycin with immune checkpoint inhibitors in sarcomas. Nature Cancer.
3. ClinicalTrials.gov (2023). Registered trials involving Dactinomycin.
4. MarketWatch Reports (2023). Oncology therapeutics market statistics.
5. FDA Database (2023). Approved oncology drugs and indications.

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