Bedaquiline fumarate is under clinical development by Johnson & Johnson and currently in Phase II for Leprosy. According to GlobalData, Phase II drugs for Leprosy does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Bedaquiline fumarate LoA Report. Buy the report here.

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Bedaquiline fumarate overview

Bedaquiline Fumarate (Sirturo) is a diarylquinoline antimycobacterial drug. It is formulated as tablets for oral route of administration. Sirturo is indicated as part of combination therapy in the treatment of adult and pediatric patients 5 years and over with pulmonary multi-drug resistant tuberculosis (MDR-TB).

It is under development for the treatment of treatment-refractory mycobacterium avium complex-lung disease, pumonary tuberculosis in adults and pediatric patients (5 years to less than 18 years of age and weighing at least 15 kg).

Bedaquiline was also under development for the treatment of multibacillary leprosy. It was under development for pulmonary multi-drug resistant tuberculosis (MDR-TB).

Johnson & Johnson overview

Johnson & Johnson (J&J) researches, develops, manufactures, and sells pharmaceutical products, medical devices, and consumer products. The company provides pharmaceuticals for immune diseases, cancer, neurological disorders, infectious, cardiovascular, and metabolic diseases; consumer products in oral care, baby care, beauty, over the counter (OTC) medicines, women’s health and wound care categories; and medical devices for use in the cardiovascular, orthopaedic, neurovascular care, general surgery and vision care fields. J&J distributes pharmaceutical and medical products to retailers, wholesalers, health care professionals and hospitals; and offers consumer products through retail outlets and distributors. The company offers its products in the US; Europe; Asia-Pacific and Africa; and Western Hemisphere (excluding the US). J&J is headquartered in New Brunswick, New Jersey, the US.

For a complete picture of Bedaquiline fumarate’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 22 April 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.