Bedaquiline fumarate is under clinical development by Johnson & Johnson and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Bedaquiline fumarate’s likelihood of approval (LoA) and phase transition for Leprosy took place on 21 Nov 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Bedaquiline fumarate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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. 

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, 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.

Quick View Bedaquiline fumarate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Bedaquiline fumarate
Administration Pathway
  • Oral
Therapeutic Areas
  • Infectious Disease
  • Respiratory
Key Developers
Highest Development Stage
  • Marketed

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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.