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Pretomanid
CAS NO.: 187235-37-6
Chemical Formula: C14H12F3N3O5
Molecular Weight: 359.2600
DMF&GMP status: Please contact us for more details.
Description:
Pretomanid is a nitroimidazooxazine antimycobacterial agent used in combination with other antituberculosis drugs in the treatment of multidrug resistant tuberculosis. The addition of pretomanid to antituberculosis drug regimens has been linked to an increased rate of transient serum liver test abnormalities during treatment and to several instances of mild, clinically apparent liver injury.

Persistent forms of tuberculosis (TB) have proven to be a major cause of global morbidity and mortality and a cause for significant concern. Research in recent years has been geared toward the development of novel therapies that target persistent forms of this disease, which have shown resistance to standard therapy regimens. Pretomanid is an antimycobacterial agent that is administered with [Bedaquiline] and [Linezolid] to treat resistant forms of pulmonary TB. It was the first TB drug developed by a nonprofit organization, known as TB Alliance, and was granted FDA approval on August 14, 2019. Unlike other therapeutic regimens for the treatment of resistant TB, which may take 18 months or longer and may not be effective, the pretomanid-containing regimen allows for a more efficacious and shorter duration of treatment with fewer drugs.

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Approvals
Active Ingredient Dosage Form; Route Strength Proprietary Name Applicant
PRETOMANIDTABLET;ORAL200MGPRETOMANIDMYLAN IRELAND LTD
Patent Data
Patent No. Patent Expiration Drug Substance Claim Drug Product Claim Patent Use Code
N.A.N.A.N.A.N.A.N.A.
Exclusive Data
Exclusivity Code Exclusivity Expiration
NCE 08/14/2024
ODE-253 08/14/2026
NCE *GAIN 08/14/2029