Otsuka MDR-Tuberculosis R&D

Program’s objectives

  1. Lead the discovery and development of new TB technologies.
  2. Evaluate the safety and efficacy of a novel compound, delamanid, in the treatment of multidrug-resistant tuberculosis (MDR-TB).
  3. Strengthen clinical trial capacity and infrastructure in selected countries affected by TB.

Because TB bacteria are so resilient, patients must take a regimen of several different medicines for anywhere from six months to a year. Because TB bacteria are so resilient, patients must take a regimen of several different medicines for anywhere from six months to a year. Copyright Riccardo Venturi/Contrasto Photo Agency

What are the health needs and challenges?

TB bacteria are so resilient that patients must take a regimen of several different medicines for anywhere from six months to a year. In the case of drug-resistant strains such as multidrug-resistant TB (MDR-TB), treatment can often last twice as long.

Description of partnership activities and how they address needs and challenges

As a recognized leader in TB R&D, Otsuka is committed to helping eliminate this devastating disease. For more than 30 years Otsuka has made TB research a priority, including strengthening clinical trial capacity and infrastructure in selected countries affected by TB. These investments have made Otsuka the current top private funder of TB drug development in the world.

In 2002, Otsuka experienced a breakthrough in its TB research with the discovery of delamanid, a nitroimidazole, which has subsequently received its first regulatory approval from the European Medicines Agency in 2014 as an oral treatment against adult pulmonary MDR-TB. Delamanid is the first from a new class of compounds that inhibit mycolic acid biosynthesis with specificity to mycobacterium TB. Since 2015, it has been included in the World Health Organization's Essential Medicines List.

The safety and efficacy of delamanid is currently undergoing further evaluation in several countries in a double-blind, placebo-controlled Phase III trial. The trial includes six months of treatment with delamanid as part of a full course of treatment with an optimized background regimen (OBR) and includes HIV co-infected MDR-TB patients.

Additionally, the company has initiated a paediatric investigation plan consisting of open-label, multi-center PK and safety trials of delamanid in children with MDR-TB in four groups of descending age from less than 18 years to birth. For the youngest groups, a novel child-friendly dispersible formulation of delamanid is being used. The studies are taking place in the Philippines and South Africa.

Since 2005, Otsuka provided over USD 450 million in funding. Delamanid received its first regulatory approval from the European Medicines Agency in 2014 for use in adult patients with pulmonary MDR-TB.

Corresponding principle in the declaration

“We are investing in a range of innovative antibiotics, vaccines, alternative technologies, and diagnostics for resistant infections. We are advancing our pipelines, but more work and investment into multiple approaches is needed to overcome the significant scientific difficulties of antibiotic discovery”

Read full Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance (AMR)


Partnership information

Company(ies) Otsuka

Therapeutic Focus Infectious Diseases

Disease(s) Drug-Resistant Infections (AMR), Tuberculosis

Program Type(s) Research & Development - Development of Treatments

Targeted Population(s) Elderly, Marginalised / Indigenous People, Men, People with low income, Women

Region(s) World

Number of Countries 1

Country(ies) Worldwide

Start Date 2004

More information Otsuka Tuberculosis

Anticipated completion date Ongoing