Drugs for Neglected Diseases Initiative

Launched in 2007, this antimalarial product is a fixed-dose combination of artesunate/amodiaquine (ASAQ). It is the result of a partnership between DNDi and Sanofi. Produced in Morocco, this product is cheap[14] (available at only $.05 for children, $1 for adults), administered in a simple regimen (1 or 2 tablets per day for 3 days), meets the latest WHO guidelines for malaria treatment in Africa and was granted "pre-qualified" status in 2008. It is included in the WHO Model List of Essential Medicines and Essential Medicines List for Children.[15][16]

ASAQ was developed with no patent.[17] ASAQ is registered in 32 African countries, in India, Ecuador and in Colombia, and included in the WHO Model List of Essential Medicines. More than 437 million treatments had been distributed.[18][19] A technology transfer agreement has been signed with industrial partner Zenufa in Tanzania in order to provide an additional source of ASAQ. ASAQ was handed over to the MMV Access and Product Management Team in May 2015.

The second antimalarial treatment developed by DNDi is a fixed-dose combination of artesunate and mefloquine launched in 2008. It was developed by an international collaboration within the FACT Project Consortium. It has a simple and adapted regimen, a 3-year shelf life and a very high compliance rate. ASMQ is produced in Brazil by Farmanguinhos/Fiocruz and thanks to a South-South technology transfer, it is now also produced by Cipla. The latter was granted "pre-qualified" status by the WHO in 2012 and included in the WHO Essential Medicines List and Essential Medicines List for Children in 2013.[20] By 2015 it was registered in Brazil, India, Malaysia, Myanmar, Tanzania, Vietnam, Niger, Burkina Faso, Thailand and Cambodia. By the end of 2015 more than one million treatments had been distributed. ASMQ was handed over to the MMV Access and Product Management Team in May 2015.

Nifurtimox-eflornithine combination treatment (NECT), a combination therapy of nifurtimox and eflornithine, is the first new, improved treatment option in 25 years for stage 2 (advanced stage) human African trypanosomiasis (HAT) also known as sleeping sickness. It is the result of a six-year partnership between NGOs, governments, pharmaceutical companies, and the WHO. It was launched in 2009 and included in the WHO Essential Medicines List and WHO Essential Medicines List for Children in 2009 and 2013 respectively. It requires shorter hospitalization than previous treatment, and is much safer than previously widely used arsenic-based melarsoprol that killed about 5% of patients. NECT is now used to treat 100% of the patients infected with HAT stage 2 in all 13 endemic countries.

SSG&PM,[21] a sodium stibogluconate plus paromomycin combination therapy, is a shorter-course, cost-efficient treatment option against visceral leishmaniasis (VL) in East Africa available since 2010. It is the result of a six-year partnership between DNDI, the Leishmaniasis East Africa Platform (LEAP), the National Control Programmes of Kenya, Sudan, Ethiopia, and Uganda, Médecins Sans Frontières (MSF) and the WHO.[22] It was recommended by the WHO Expert Committee on the Control of Leishmaniasis in 2010 as the first-line treatment in East Africa, and more than 10,000 patients have been treated. Sudan, Ethiopia, South Sudan and Somalia have released revised guidelines recommending SSG&PM as the first-line treatment for VL.

Single dose amphotericin B and paromomycin/miltefosine/amphotericin B combinations were recommended by the WHO Expert Committee on the Control of Leishmaniasis (2010).[23] These treatments are less toxic than previous mainstay treatments, useful in areas of antimonial resistance, are shorter course and their cost is comparable with previous treatments. In 2010, a study investigating the three possible 2-drug combinations of amphotericin B, miltefosine and paromomycin was completed in India. All three combination treatments were shown to be highly efficacious (> 97.5% cure rate). A WHO Expert committee recommended these treatments to be used preferentially to current established monotherapy treatments for VL in South Asia. DNDi is working with TDR and WHO to facilitate their introduction and support VL elimination strategies.[24] DNDi conducted more studies, including a pilot project in the Bihar State of India (2012-2015) that demonstrated the safety and effectiveness of combination therapies based on amphotericin B, miltefosine, and paromomycin at the primary healthcare level, and single dose amphotericin B at the hospital level. Based on the study results, the Indian National Roadmap for Kala-Azar Elimination in August 2014 recommended use of single dose amphotericin B as a first option treatment for the treatment of VL patients, with paromycin and miltefosine as a second option at all levels;[25] a policy also reflected in Bangladesh and Nepal. this removal of miltefosine monotherapy is an important policy change. This project has been a collaboration with the National (Vector Borne) Disease Control Programmes of India and Bangladesh, MSF, TDR, OneWorld Health/PATH, Bihar State Health Society, and the Indian Council for Medical Research.

This is the only paediatric dosage treatment for Chagas disease, launched in 2011 through a collaboration between DNDi and Laboratório Farmacêutico do Estado de Pernambuco (LAFEPE). In November 2013, the Mundo Sano Foundation and DNDi signed a collaboration agreement to deliver a second source of the treatment in partnership with ELEA. The paediatric dosage form of benznidazole is designed for infants and young children under 2 years of age (20 kg body weight) infected congenitally. Thanks to its age-adapted, easy-to-use, affordable, and non-patented tablet, the new treatment contributes to improved dosing accuracy, safety, and adherence to treatment. The paediatric dosage form of benznidazole was granted registration by Brazil's National Health Surveillance Agency in 2011, and further endemic countries are targeted for obtaining registration. It was included on the WHO Essential Medicines List for Children in July 2013.[26]

Among the many challenges of treating children co-infected with both tuberculosis (TB) and HIV is the fact that a key TB drug negates the effectiveness of ritonavir, one of the main aniretrovirals to treat HIV. A DNDi-sponsored study[27] at five hospitals in South Africa demonstrated the effectiveness of ‘super-boosting’ or adding extra ritonavir to a child’s treatment regimen. WHO has since strengthened recommendations to use super-boosting in TB/HIV co-infected children.[28]

Fexinidazole is the first entirely oral treatment for sleeping sickness (or human african trypanosomiase) due to Trypanosoma brucei gambiense. It was developed in partnership by DNDi, Sanofi, and other partners. The clinical trials enrolled 749 patients from the Democratic Republic of the Congo and the Central African Republic. The results published in The Lancet showed high efficacy and safety for both stages of the disease. Fexinidazole is administered in pills for 10 days.[29]

In November 2018, the European Medicines Agency adopted a positive scientific opinion of fexinidazole.[30][31][32] In December 2018, fexinidazole was approved in the Democratic Republic of the Congo.[33]

Other project:

In 2016, in collaboration with the World Health Organization, DNDi launched the Global Antibiotic Research & Development Partnership (GARDP), a not-for-profit research and development organization that addresses global public health needs by developing and delivering new or improved antibiotic treatments, while endeavouring to ensure their sustainable access. In 2018, GARDP set up as an independent legal entity.[34]