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Cosmegen

(dactinomycin)

ApprovedBiologic

RRECORDATI GROUP

This medication is a chemotherapy drug that belongs to the antibiotic class and is used to treat various cancers including kidney tumors in children, muscle cancers, testicular cancer, bone tumors, and pregnancy-related tumors. It works by slowing or stopping the growth of cancer cells in the body.[2] Cosmegen is currently approved and in use across 8 indications[4].[1]

Cosmegen is one of 71 biologic programs targeting Rhabdomyosarcoma. It is currently in Approved.

8

Indications

44

Total Trials

12

Active Trials

70

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

RhabdomyosarcomaActive, not recruiting

Kidney Wilms TumorActive, not recruiting

Ewing SarcomaActive, not recruiting

Gestational Trophoblastic NeoplasmApproved

Stage I Mixed Cell Type Kidney Wilms TumorRecruiting

Pleuropulmonary BlastomaRecruiting

Radiation TherapyActive, not recruiting

Wilms TumorActive, not recruiting

RhabdomyosarcomaPhase 3

Active, not recruiting

Kidney Wilms TumorApproved

Active, not recruiting

Ewing SarcomaPreclinical

Active, not recruiting

Gestational Trophoblastic NeoplasmApproved

Approved

Stage I Mixed Cell Type Kidney Wilms TumorPhase 3

Recruiting

Pleuropulmonary BlastomaPhase 3

Recruiting

Radiation TherapyPhase 3

Active, not recruiting

Wilms TumorPhase 3

Active, not recruiting

Competition

Competitive Landscape

36 competitors in Rhabdomyosarcoma

#DrugCompanyPhaseTrials

Cosmegen

RRECORDATI GROUP

Oncovin

Verzenio

Cytoxan

BBaxter Healthcare Corporation

Camptosar

Adriamycin

Oncovin

Ifex

BBaxter Healthcare Corporation

Vepesid

Neupogen

EEastern Cooperative Oncology Group

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Rhabdomyosarcoma

NCT02567435

Q3 2027

Phase 3Active, not recruiting

Rhabdomyosarcoma

NCT04994132

Q4 2028

N/AActive, not recruiting

Treatment

NCT01464606

Q1 2029

Phase 3Recruiting

Pleuropulmonary Blastoma

NCT06647953

Clinical

Trials by Indication[1]

Rhabdomyosarcoma17 trials

Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma

Completed·CChildren's Oncology Group·Phase 3·NCT00075582·390 enrolled

Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01055314·175 enrolled

Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

Completed·CChildren's Oncology Group·Phase 3·NCT00354835·481 enrolled

Show 14 more trials

Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT01871766·115 enrolled

Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease

Recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT06023641·135 enrolled

Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma

Unknown status·JJapan Rhabdomyosarcoma Study Group·Phase 2·NCT00245089·41 enrolled

Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma

Unknown status·JJapan Rhabdomyosarcoma Study Group·Phase 2·NCT00245141·32 enrolled

Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors

Completed·SSociete Internationale d'Oncologie Pediatrique·Phase 2·NCT00025441

Combination Chemotherapy in Treating Young Patients With Nonmetastatic Rhabdomyosarcoma

Unknown status·EEuropean Paediatric Soft Tissue Sarcoma Study Group·Phase 3·NCT00379457·600 enrolled

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

Completed·CChildren's Oncology Group·Phase 3·NCT00002995·483 enrolled

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Metastatic Rhabdomyosarcoma or Sarcoma

Completed·CChildren's Oncology Group·Phase 2·NCT00003955·77 enrolled

Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma

Completed·CChildren's Oncology Group·Phase 3·NCT00003958·702 enrolled

High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma

Completed·CChildren's Oncology Group·Phase 3·NCT00354744·109 enrolled

A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating With Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients With Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT02567435·325 enrolled

A Randomized Phase 3 Study to Compare VAC (Higher Cyclophosphamide Dose and Intensity) Versus VAC/VI (Lower Cyclophosphamide Dose and Intensity) Plus Maintenance Therapy in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma

Recruiting·CChildren's Oncology Group·Phase 3·NCT07466316·342 enrolled

A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma

Recruiting·CChildren's Oncology Group·Phase 3·NCT05304585·205 enrolled

A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy With Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) Plus VINO-CPO Maintenance in Patients With High Risk Rhabdomyosarcoma (HR-RMS)

Active, not recruiting·CChildren's Oncology Group·Phase 3·NCT04994132·113 enrolled

Radiation Therapy4 trials

Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors

Completed·CChildren's Oncology Group·Phase 2·NCT00335556·291 enrolled

Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT

Completed·—·Phase 2·NCT00084838·25 enrolled

Combination Chemotherapy Plus Surgery and Radiation Therapy in Treating Patients With Ewing's Sarcoma

Unknown status·UUniversity Hospital Muenster·Phase 3·NCT00002516

Show 1 more trial

Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor

Active, not recruiting·CChildren's Oncology Group·Phase 3·NCT00352534·808 enrolled

Methotrexate3 trials

Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia

Active, not recruiting·Xxiang yang·N/A·NCT04562558·228 enrolled

Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

Completed·GGynecologic Oncology Group·Phase 3·NCT00003702·240 enrolled

Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia

Completed·GGOG Foundation·Phase 3·NCT01535053·57 enrolled

Soft Tissue Sarcoma2 trials

Isolated Limb Infusion of Chemotherapy in Treating Patients With Melanoma or Soft Tissue Sarcoma of the Arm or Leg That Cannot Be Removed By Surgery

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00004250·35 enrolled

Surgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma

Completed·SSociete Internationale d'Oncologie Pediatrique·Phase 3·NCT00002898·400 enrolled

Stem Cell Transplantation2 trials

Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma

Unknown status·UUniversity of Leicester·Phase 3·NCT00020566·1,200 enrolled

Chemotherapy With or Without Surgery, Radiation Therapy, or Stem Cell Transplantation in Treating Young Patients With Kidney Tumors

Completed·CChildren's Oncology Group·Phase 3·NCT00002610·203 enrolled

14 more indications

Treatment2 trials

International Pleuropulmonary Blastoma (PPB) Treatment and Biology Registry

Active, not recruiting·—·N/A·NCT01464606·156 enrolled

Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors

Terminated·TTufts Medical Center·Phase 3·NCT01014767·27 enrolled

Chemotherapy2 trials

Chemotherapy Plus Surgery in Treating Children at Risk of or With Stage I Wilms' Tumor

Unknown status·UUniversity of Leicester·Phase 3·NCT00003804·350 enrolled

Chemotherapy Before and After Surgery in Treating Children With Wilm's Tumor

Unknown status·UUniversity of Leicester·Phase 3·NCT00047138·350 enrolled

Relapse1 trial

GAMEC-II, Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT)

Completed·QQueen Mary University of London·Phase 2·NCT06309732·36 enrolled

Melanoma1 trial

Isolated Limb Infusion Chemotherapy With Targeted Gene Therapy for Advanced, Unresectable Extremity Melanoma

Withdrawn·WWashington University School of Medicine·Phase 1/2·NCT01531244

Leukemia1 trial

Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 3·NCT00002766·170 enrolled

Germ Cell Tumor1 trial

Combination Chemotherapy in Treating Children With Non-testicular Malignant Germ Cell Tumors

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00002489

Wilms tumor1 trial

Combination Chemotherapy and Surgery in Treating Young Patients With Wilms Tumor

Active, not recruiting·CChildren's Oncology Group·Phase 3·NCT00945009·249 enrolled

Fibrosarcoma1 trial

Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma

Terminated·CChildren's Oncology Group·Phase 2·NCT00072280·7 enrolled

Kidney Cancer1 trial

Combination Chemotherapy Alone or With Radiation Therapy in Treating Children With Kidney Cancer

Completed·CChildren's Oncology Group·Phase 3·NCT00002611·3,031 enrolled

Recurrent1 trial

Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia

Completed·GGynecologic Oncology Group·Phase 2·NCT00003688

Relapsed or Refractory1 trial

Chemotherapy Followed by Surgery and Radiation Therapy With or Without Stem Cell Transplant in Treating Patients With Relapsed or Refractory Wilms' Tumor or Clear Cell Sarcoma of the Kidney

Unknown status·CChildren's Cancer and Leukaemia Group·Phase 2·NCT00025103·75 enrolled

Pleuropulmonary Blastoma1 trial

Prospective Treatment of Types I, II and III Pleuropulmonary Blastoma (PPB)

Recruiting·CChildren's Oncology Group·Phase 3·NCT06647953·110 enrolled

Stage I Mixed Cell Type Kidney Wilms Tumor1 trial

Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)

Recruiting·CChildren's Oncology Group·Phase 3·NCT06401330·1,656 enrolled

Stage III Kidney Wilms Tumor1 trial

Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Completed·CChildren's Oncology Group·Phase 3·NCT00379340·395 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

COSMEGEN

NDA NDA050682

Sources

References

[1]
ClinicalTrials.gov — 44 trial records for dactinomycin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cosmegen drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — dactinomycin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for dactinomycin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA050682). U.S. Food & Drug Administration.
[6]
SEC EDGAR — RECORDATI GROUP company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[3]
Highest Phase: Approved[1]
Company: RRECORDATI GROUP

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