Request for Information and Urgent Appeal to Accelerate Compassionate Use Access to Quabodepistat

30 April 2025

Advocates appeal to Otsuka to establish a compassionate use program for quabodepistat.

On 30 April 2025, the Global Tuberculosis Community Advisory Board (TB CAB) sent an open letter to Otsuka requesting an update regarding the company’s plans and timelines for establishing a compassionate use program for quabodepistat.

“Otsuka’s leadership in establishing a compassionate use program for delamanid set an important precedent and demonstrated the value of such programs for meeting the needs of individuals with limited therapeutic options and the TB programs and clinicians responsible for their care, and for generating important information necessary to support policy making, especially for the use of new drugs among populations typically excluded from formal clinical trials. We urge similar action to establish a compassionate use program for quabodepistat.”

Results from the phase 2b/c trial presented during the 2024 Union Conference in Bali, Indonesia provides early proof of the efficacy and safety of quabodepistat, prerequisite criteria for pre-approval access to new drugs in situations of unmet medical need.

The TB CAB requested a written response to the letter by 14 May 2025.

Download the open letter here.