NOV-002

Overview

NOV-002, the lead compound acts as a chemoprotectant and an immunomodulator, in combination with chemotherapy. NOV-002 is approved and marketed in the Russian Fereration by Pharma BAM under the trade name Glutoxim. It has been administered to over 10,000 patients, demonstrating clinical efficacy and excellent safety data.

Indication

Investigated for use/treatment in breast cancer, lung cancer, and ovarian cancer.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
NOV-002 in Myelodysplastic Syndrome (MDS)	2009/08/18	NCT00960726	Phase 2	Withdrawn	M.D. Anderson Cancer Center
NOV-002, Doxorubicin, Cyclophosphamide, and Docetaxel in Women With Newly Diagnosed Stage II or IIIC Breast Cancer	2007/07/11	NCT00499122	Phase 2	Completed	University of Miami
Study of NOV-002 in Combination With Chemotherapy to Treat Lung Cancer	2006/07/04	NCT00347412	Phase 3	Completed	Cellectar Biosciences, Inc.
Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-resistant Ovarian Cancer	2006/06/28	NCT00345540	Phase 2	Completed	Cellectar Biosciences, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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