Drugs for Neglected Diseases Initiative

The Drugs for Neglected Diseases Initiative (DNDi) is a collaborative, patient-needs-driven nonprofit organization that develops and helps deliver treatments for diseases neglected by mainstream pharmaceutical research. It was established in 2003 in response to a persistent gap between the global burden of tropical and poverty-associated diseases and the number of new medicines developed for them. Its work is aimed especially at people living in low- and middle-income countries, where diseases such as visceral leishmaniasis, Chagas disease, sleeping sickness, malaria, and filarial infections can cause severe disability or death but offer limited commercial returns. DNDi emerged from a partnership involving Médecins Sans Frontières (MSF), the Oswaldo Cruz Foundation in Brazil, the Indian Council of Medical Research, the Kenya Medical Research Institute, Malaysia's Ministry of Health, and France's Pasteur Institute. The World Health Organization's Special Programme for Research and Training in Tropical Diseases acts as a permanent observer. MSF used part of the funds associated with its 1999 Nobel Peace Prize to provide seed financing. Bernard Pécoul, previously associated with MSF's humanitarian and access-to-medicines work, led the initiative from its creation through 2022. Luis Pizarro became executive director in 2022. Rather than operating as a conventional pharmaceutical company, DNDi coordinates a distributed product-development network. It combines the capabilities of public research institutes, universities, endemic-country health authorities, pharmaceutical and biotechnology companies, nongovernmental organizations, and other product-development partnerships. This model allows the organization to identify promising compounds, conduct or coordinate preclinical and clinical studies, support regulatory work, arrange manufacturing and technology transfer, and pursue affordable access. DNDi's approach is associated with delinkage: the cost and incentives of research and development should be separated from the price charged for the resulting medicine, so that products can be affordable without eliminating the incentive to develop them. The initiative's portfolio has covered leishmaniasis, human African trypanosomiasis or sleeping sickness, Chagas disease, malaria, filarial diseases, mycetoma, paediatric HIV, cryptococcal meningitis, hepatitis C, and dengue. Its work has produced or supported treatments including the antimalarial combinations ASAQ and ASMQ, NECT for advanced sleeping sickness, sodium stibogluconate plus paromomycin for visceral leishmaniasis in East Africa, paediatric benznidazole for Chagas disease, fexinidazole for gambiense sleeping sickness, and a ravidasvir-based hepatitis C regimen. DNDi's malaria activities were transferred to Medicines for Malaria Venture in 2015. DNDi is headquartered in Geneva and has offices or operational presence in several disease-endemic and research locations, including Brazil, the Democratic Republic of the Congo, India, Japan, Kenya, and Malaysia, as well as an affiliate in the United States. Its current identity is that of a global nonprofit research-and-development partnership rather than a consumer-facing pharmaceutical brand. The organization continues to emphasize treatments that are effective, practical in resource-limited settings, suitable for children where relevant, affordable, and capable of being supplied sustainably.

DNDi was formed in 2003 against the background of a severe imbalance in pharmaceutical innovation. Diseases concentrated among poorer populations accounted for a substantial share of global illness, yet only a very small proportion of newly approved medicines addressed neglected diseases. Conventional market incentives were insufficient because many affected patients and public health systems could not support prices or sales volumes comparable with those of medicines for wealthier markets. The initiative was established by MSF together with public research and health institutions from Brazil, India, Kenya, Malaysia, and France. Its seed financing came from MSF's Nobel Peace Prize funds, while WHO's Special Programme for Research and Training in Tropical Diseases became a permanent observer. Bernard Pécoul served as the founding executive director and guided the organization through its formative period. DNDi adopted a product-development-partnership model. Instead of building a fully integrated pharmaceutical company, it acts as a coordinator across a virtual network of laboratories, universities, governments, manufacturers, clinical investigators, NGOs, and pharmaceutical companies. The organization can repurpose existing compounds, combine known medicines, develop new chemical entities, and establish manufacturing and distribution arrangements. A central objective is to ensure that the resulting products are suitable for endemic settings: simple dosing, heat stability where possible, child-friendly formats, manageable toxicity, and prices compatible with public procurement. Its first major medicines included ASAQ, a fixed-dose artesunate-amodiaquine malaria treatment launched with Sanofi in 2007, and ASMQ, an artesunate-mefloquine combination launched in 2008 through the FACT project consortium. NECT followed in 2009 for advanced sleeping sickness, replacing more hazardous and difficult treatment approaches. In 2010 DNDi and partners supported sodium stibogluconate plus paromomycin as a shorter-course visceral-leishmaniasis regimen in East Africa. During the same period, the organization helped advance combination strategies for visceral leishmaniasis in South Asia, including single-dose liposomal amphotericin B and combinations involving miltefosine or paromomycin. In 2011, DNDi and LAFEPE introduced a paediatric benznidazole formulation for Chagas disease. The dosage form was designed for infants and young children and was later supported by additional manufacturing and access collaborations. DNDi also worked on HIV and tuberculosis co-infection in children, with evidence supporting intensified ritonavir dosing when rifampicin-based tuberculosis treatment reduced antiretroviral exposure. The organization expanded beyond its original disease priorities. In 2015 its malaria product-management activities were transferred to Medicines for Malaria Venture. In 2016 DNDi and WHO launched the Global Antibiotic Research and Development Partnership, which became an independent legal entity in 2018. DNDi also developed a hepatitis C program around ravidasvir and sofosbuvir, with clinical work in Malaysia and Thailand producing high cure rates and Malaysia granting conditional registration in 2021. Fexinidazole became one of DNDi's most prominent achievements. Developed with Sanofi and other partners, it provided the first entirely oral treatment for gambiense sleeping sickness and was approved in the Democratic Republic of the Congo in 2018 after a favorable European regulatory opinion. DNDi has subsequently continued work on visceral leishmaniasis, leishmaniasis-HIV co-infection, mycetoma, filarial diseases, paediatric HIV, cryptococcal meningitis, hepatitis C, and other conditions. Pécoul left the executive-director role in 2022 and was succeeded by Luis Pizarro. DNDi remains a Geneva-based international nonprofit with offices and affiliates in multiple countries. Its long-term model combines scientific development with access planning, technology transfer, non-exclusive or public-interest-oriented partnerships, and advocacy for research systems that do not depend solely on high medicine prices.

• 2022

  Leadership transition

  [3]DNDi people and leadershipdndi.org

  Luis Pizarro succeeds Bernard Pécoul as executive director.

• 2021

  Ravidasvir conditionally registered in Malaysia

  [6]Ravidasvir portfoliodndi.org

  Malaysia grants conditional registration to the hepatitis C drug candidate ravidasvir.

• 2018

  Fexinidazole approved in the Democratic Republic of the Congo

  [5]Fexinidazole portfoliodndi.org

  The first all-oral treatment for gambiense sleeping sickness receives national approval.

• 2016

  GARDP launched

  [7]Global Antibiotic Research and Development Partnershipgardp.org

  DNDi and WHO establish the Global Antibiotic Research and Development Partnership.

• 2015

  Malaria activities transferred to MMV

  [12]Malaria activities transferred to MMVdndi.org

  DNDi hands malaria access and product-management responsibilities to Medicines for Malaria Venture.

• 2011

  Paediatric benznidazole launched

  [11]Paediatric benznidazole launcheddndi.org

  A child-adapted benznidazole treatment for Chagas disease is registered in Brazil.

• 2009

  NECT introduced for sleeping sickness

  [10]NECT introduced for sleeping sicknessdndi.org

  Nifurtimox-eflornithine combination therapy becomes an improved option for advanced human African trypanosomiasis.

• 2008

  ASMQ malaria treatment launched

  [9]ASMQ malaria treatment launcheddndi.org

  An artesunate-mefloquine fixed-dose combination is introduced through the FACT consortium.

• 2007

  ASAQ malaria treatment launched

  [8]ASAQ malaria treatment launcheddndi.org

  DNDi and Sanofi introduce an affordable fixed-dose artesunate-amodiaquine combination.

• 2003

  DNDi is established

  [4]DNDi historydndi.org

  MSF and public research and health institutions create DNDi to develop treatments for neglected diseases.

A nonprofit, access-oriented product-development partnership that turns public-health and scientific collaborations into safe, effective, affordable treatments for neglected diseases.

• Malaria treatment · 2007

  ASAQ

  A fixed-dose combination of artesunate and amodiaquine developed with Sanofi. Launched in 2007, it uses a short three-day regimen and was designed to meet malaria-treatment needs in Africa. The product was developed without a patent, received WHO prequalification, and was transferred to Medicines for Malaria Venture for ongoing access and product-management activities.

• Malaria treatment · 2008

  ASMQ

  A fixed-dose artesunate-mefloquine combination developed through the FACT project consortium. The formulation was intended to simplify treatment, improve adherence, and support use in endemic settings. It was produced through partnerships involving Farmanguinhos/Fiocruz and Cipla, with technology transfer supporting additional supply.

• Sleeping-sickness treatment · 2009

  NECT

  Nifurtimox-eflornithine combination therapy for stage-two human African trypanosomiasis. Introduced in 2009 after collaboration among DNDi, WHO, governments, NGOs, and pharmaceutical partners, NECT shortened hospitalization and provided a safer alternative to older arsenic-based therapy. It became a key treatment option across endemic countries.

• Visceral-leishmaniasis treatment · 2010

  SSG plus paromomycin

  A combination regimen developed for visceral leishmaniasis in East Africa. It offered a shorter and more practical course than some earlier therapies and was recommended as a first-line option in the region following work with national programs, MSF, WHO, and the Leishmaniasis East Africa Platform.

• Chagas-disease treatment · 2011

  Paediatric benznidazole

  A child-adapted dosage form of benznidazole developed with LAFEPE for infants and young children, including those infected congenitally. Its tablet design improves dosing accuracy and ease of administration compared with adapting adult formulations. The product was registered in Brazil and included on the WHO Essential Medicines List for Children.

• Sleeping-sickness treatment · 2018

  Fexinidazole

  An entirely oral ten-day treatment for gambiense human African trypanosomiasis. Developed with Sanofi and other partners, it was studied in patients from the Democratic Republic of the Congo and the Central African Republic. Its oral route reduces the logistical burden associated with injectable treatment and it received approval in the Democratic Republic of the Congo in 2018.

• Hepatitis C treatment · 2021

  Ravidasvir

  A direct-acting antiviral studied with sofosbuvir for an affordable hepatitis C regimen in low- and middle-income countries. DNDi worked with Presidio Pharmaceuticals, Pharco Pharmaceuticals, and health ministries in Malaysia and Thailand. Clinical studies reported a high sustained cure rate, and Malaysia granted conditional registration in 2021.

• 2021

  Support conditional registration of ravidasvirProduct launch

  Background

  Affordable direct-acting antiviral access remained limited in many low- and middle-income countries.

  Action taken

  DNDi supported clinical development of ravidasvir with sofosbuvir and partners in Malaysia and Thailand.

  Aftermath

  Malaysia granted conditional registration to ravidasvir.

  Source

• 2018

  Advance fexinidazole into regulatory useProduct launch

  Background

  Sleeping-sickness treatment required options that were safer and easier to administer than older therapies, especially in remote endemic settings.

  Action taken

  DNDi and its partners completed clinical development and pursued regulatory review for oral fexinidazole.

  Aftermath

  The European Medicines Agency issued a positive scientific opinion and the Democratic Republic of the Congo approved the medicine.

  Source

• 2016

  Create the Global Antibiotic Research and Development PartnershipStrategy

  Background

  Antibiotic resistance created a need for nonprofit research and development models that could address treatments unattractive to conventional commercial investment.

  Action taken

  DNDi and WHO launched GARDP to develop and support access to new or improved antibiotic treatments.

  Aftermath

  GARDP became an independent legal entity in 2018.

  Source

• 2015

  Transfer malaria product-management activities to MMVStrategy

  Background

  DNDi had developed malaria products including ASAQ and ASMQ but sought a specialized long-term access and product-management structure for its malaria portfolio.

  Action taken

  DNDi transferred malaria access and product-management activities to Medicines for Malaria Venture.

  Aftermath

  MMV became responsible for the relevant malaria portfolio activities while DNDi continued focusing on its broader neglected-disease research agenda.

  Source

1. 1Drugs for Neglected Diseases Initiativeen.wikipedia.org
2. 2DNDi official websitedndi.org
3. 3DNDi people and leadershipdndi.org
4. 4DNDi historydndi.org
5. 5Fexinidazole portfoliodndi.org
6. 6Ravidasvir portfoliodndi.org
7. 7Global Antibiotic Research and Development Partnershipgardp.org
8. 8ASAQ malaria treatment launcheddndi.org
9. 9ASMQ malaria treatment launcheddndi.org
10. 10NECT introduced for sleeping sicknessdndi.org
11. 11Paediatric benznidazole launcheddndi.org
12. 12Malaria activities transferred to MMVdndi.org