Purini® is the commercial brand name of Pretomanid Tablets, manufactured by Shenyang Hongqi Pharmaceutical Co., Ltd. It is a novel oral anti-mycobacterial agent with a unique mechanism of action. It targets mycobacterial cell wall synthesis and energy metabolism, exerting potent bactericidal activity against extensively drug-resistant Mycobacterium tuberculosis when combined with bedaquiline and linezolid.
Main Indications
Combined use with bedaquiline and linezolid for the 6-month treatment of adults with extensively drug-resistant pulmonary tuberculosis, when no other effective therapeutic regimens are available.
Clinical Research
Global pivotal phase III trials fully validated the high culture conversion rate of the BPaL three-drug combination regimen for XDR-TB patients;
Registration comparative studies confirmed shortened treatment cycle and improved treatment completion rate versus traditional long-course anti-tuberculosis regimens;
Multinational cohort follow-up trials demonstrated sustained low relapse risk after completion of the 6-month BPaL treatment course;
Dose-finding research verified balanced anti-tubercular efficacy and hepatic safety of the 200mg once-daily oral dose;
Chinese domestic clinical trials confirmed favorable efficacy and manageable adverse reaction spectrum for local drug-resistant tuberculosis populations.
Common Side Effects
Common mild adverse reactions: Nausea, vomiting, headache, acne, abdominal pain, rash, pruritus and decreased appetite;
Laboratory abnormalities: Elevated liver transaminases, anemia, increased amylase and QT interval prolongation;
Severe but uncommon risks: Severe liver toxicity, severe peripheral neuropathy, severe myelosuppression and life-threatening arrhythmia.
Approval Status in China
Original drug Purini® (Pretomanid Tablets) obtained marketing approval in China in December 2024, with the specification of 200mg per tablet, 26 tablets per box. It is a prescription anti-tuberculosis drug included in China’s Category B medical insurance catalogue starting from 2026.
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