Bedaquiline Fumarate (CAS 845533-86-0)
Google Keywords: Bedaquiline Fumarate CAS 845533-86-0, MDR-TB Treatment API, ATP Synthase Inhibitor, WHO-Prequalified Tuberculosis Drug, GMP Antimycobacterial Synthesis
🌟 Product Overview
Bedaquiline Fumarate (CAS 845533-86-0) is a first-in-class diarylquinoline antimycobacterial agent approved for the treatment of multidrug-resistant tuberculosis (MDR-TB). It selectively inhibits mycobacterial ATP synthase, disrupting energy production in Mycobacterium tuberculosis while sparing human mitochondria. This API is pivotal in shortening MDR-TB treatment regimens and improving patient outcomes.
Primary Function: Targets drug-resistant TB strains with a novel mechanism of action, reducing treatment duration from 18–24 months to 6–9 months.
Applications: MDR-TB therapy, combination regimens for extensively drug-resistant TB (XDR-TB), and WHO-recommended TB control programs.
✅ Key Advantages
🔹 High Efficacy | 90% culture conversion rate in Phase III trials | Superior to traditional TB therapies for resistant strains.
🔹 Selective Action | 10,000x higher affinity for bacterial ATP synthase vs. human cells | Minimizes systemic toxicity.
🔹 WHO-Prequalified | Listed in WHO Essential Medicines for MDR-TB | Accelerates global regulatory approvals.
🔹 Stability | Shelf life of 36 months under controlled storage (2–8°C, protected from light).
🧪 Applications
MDR/XDR-TB Treatment: Core component of WHO-endorsed 6-month oral regimens (e.g., with pretomanid and linezolid).
Hospital Formulations: Used in injectable and oral dosage forms for severe TB cases.
Public Health Programs: Distributed in high-TB burden countries (e.g., India, South Africa) via Global Fund partnerships.
Research: Investigated for nontuberculous mycobacteria (NTM) infections.
📜 Quality Assurance
Testing Methods: HPLC (purity ≥98.5%), GC (residual solvents), XRD (polymorph characterization), and microbial limits per USP <61>.
Standards: Complies with ICH Q3A/B, USP <823>, and EMA guidelines for antitubercular APIs.
📈 Market Trends
The global MDR-TB therapeutics market is projected to grow at 8.7% CAGR through 2030, driven by rising MDR-TB cases (≈500,000 annually) and expanded access initiatives. Bedaquiline’s inclusion in WHO guidelines and patent expirations post-2023 are expected to boost generic API demand, particularly in Asia and Africa.
Transform MDR-TB care with Bedaquiline Fumarate – engineered for potency, safety, and alignment with global health priorities.
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