Drugs for Neglected Diseases Initiative, North America Inc.

aka DNDi North America   |   New York, NY   |


The Drugs for Neglected Diseases initiative (DNDi), North America is an international non-profit organization that discovers, develops, and delivers safe, effective, and affordable treatments for the most neglected patients in some of the world's most impoverished communities.

Ruling year info


Executive Director

Rachel M Cohen

Main address

40 Rector Street 16th Floor

New York, NY 10006 USA

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NTEE code info

Diseases, Disorders, Medical Disciplines N.E.C. (G99)

Research Institutes and/or Public Policy Analysis (H05)

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This organization is required to file an IRS Form 990 or 990-EZ.

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Programs and results

What we aim to solve

SOURCE: Self-reported by organization

Millions of people around the world die every year from lack of treatment. Yet only a fraction of the world’s pharmaceutical research and development focuses on diseases affecting poor and vulnerable communities. The Drugs for Neglected Diseases initiative (DNDi) was created as a response to the frustration of clinicians and the desperation of patients faced with medicines that were ineffective, highly toxic, unavailable, unaffordable – or that had never been developed at all. The root of the problem? The prevailing profit-oriented model for medical research and development (R&D) leaves little incentive to develop drugs for the poorest and most vulnerable communities

Our programs

SOURCE: Self-reported by organization

What are the organization's current programs, how do they measure success, and who do the programs serve?

Human African Trypanosomiasis (HAT)

At its inception, DNDi’s short-term strategy was to make better use of existing treatments by combining drugs already in use. In September 2009, DNDi and partners launched the first new treatment for sleeping sickness in 25 years: nifurtimox and eflornithine combination therapy (NECT). NECT is included on the WHO Essential Medicines Lists (EML) for adults (since 2009) and children (since 2013), and all countries with endemic T. b. gambiense are now using NECT as first-line treatment for stage 2 HAT.

As a medium-term strategy, DNDi initiated a compound mining effort to identify existing chemical compounds with potential against kinetoplastid diseases, resulting in the rediscovery of fexinidazole, currently undergoing evaluation in a pivotal Phase II/III study in stage 2 HAT, with two complementary studies examining efficacy and safety in adults with stage 1 and early stage 2 HAT, and in children aged 6-14 years. Sanofi is the industrial partner.

In order to build a strong pipeline for long-term drug discovery, DNDi established a HAT Lead Optimization Consortium resulting in identification of the oxaborole SCYX-7158, which successfully progressed through pre-clinical development. Phase I clinical development is due for completion in 2015. Other backup compounds were evaluated by the consortium and remain available for further development if necessary.

In addition, DNDi supports the HAT Platform that was launched in Kinshasa, Democratic Republic of the Congo (DRC) in 2005. The HAT Platform is a clinical research and access-supporting network that brings together key players in the fight against sleeping sickness in endemic countries and those involved in HAT from the international research arena.

Ideally a new treatment for adults and children would be effective against both stages of the disease and both parasite sub-species, non-toxic, at least 95% efficacy at 18 months follow-up, safe for pregnant and breastfeeding women, easy to use (short-course or once a day), oral, requiring no monitoring, affordable and adapted to tropical climates.

By 2018, DNDi aims to deliver from its HAT-specific portfolio:
- An oral, safe, effective treatment to be used for both stage two and stage one HAT

Population(s) Served

Visceral Leishmaniasis
DNDi’s short-term approach for visceral leishmaniasis was to develop new treatments by combining existing drugs and/or shortening treatment duration in order to increase tolerability, reduce burden on health systems, and offer greater affordability, whilst also preventing or delaying emergence of resistance. Another objective is the geographical extension of existing drugs in other countries and regions. In 2010, DNDi and LEAP partners delivered the SSG&PM combination therapy for East Africa, now recommended as first-line treatment for VL in the region. SSG&PM has been included in the national guidelines of Sudan, South Sudan, Ethiopia, and Kenya. PM is registered in Uganda (2011) and Kenya (2013), and is in the process of registration in Sudan and Ethiopia. In India, a Phase III trial demonstrated the efficacy of combination therapies of already registered drugs. In 2014, the government of India recommended use of single-dose AmBisome® as a first option and paromomycin/miltefosine combination as the second option for treatment instead of using miltefosine as monotherapy. DNDi has collaborated with the National Control Programmes of India and Bangladesh, MSF, the Bihar State Health Society, and the Indian Council for Medical Research to assess the effectiveness and safety of these new treatments at the primary healthcare level and facilitate their introduction. In Latin America, DNDi is participating in a study sponsored by the Brazilian Innovation Agency (FINEP) to evaluate the safety and efficacy of Glucantime®, AmBisome®, and amphotericin B as monotherapies, and of AmBisome®/Glucantime® combination to treat VL patients. The national control programme has extended the use of AmBisome® as second-line treatment based on the interim safety data from this trial.

Leishmania and HIV co-infection is a growing problem, difficult to manage clinically due to poor response to treatment with frequent relapses of disease, and is eventually fatal. DNDi is working with partners towards better treatment for HIV/VL co-infected patients in Africa using existing drugs at different dose/regimen and in combination, and is collaborating with ITM-Antwerp in a secondary prophylaxis study.

In the medium term, DNDi is assessing the combination of fexinidazole and miltefosine for the treatment of visceral leishmaniasis patients in terms of efficacy and safety. This could be the first oral-only combination therapy for visceral leishmaniasis.

DNDi’s long-term strategy for visceral leishmaniasis is to bring new oral drug candidates into clinical development through its lead optimization programme with the ultimate goal of improving the safety profile and efficacy of the existing tools with a second oral-only combination treatment.

In addition, DNDi supports the Leishmaniasis East Africa Platform (LEAP). A new visceral leishmaniasis treatment for adults and children based on a new chemical entity would ideally be efficacious against all species of Leishmania in all regions as well as against resistant strains, have at least 95% efficacy, be short course (once a day for 10 days oral; or 3 shots over 10 days), easy to use, compatible for combination therapy, safe in pregnant and breastfeeding women and for immunocompetent/immunosuppressed patients, affordable, and adapted to tropical climates.

By 2020, DNDi aims to deliver from its VL-specific portfolio:
- Potentially a safe, effective, low-cost, and short-course oral combination treatment
- A new treatment for PKDL that is shorter course and better tolerated than current options
- Treatment options for HIV/VL co-infected patients
- A new first-line treatment regimen for visceral leishmaniasis in Latin America

Cutaneous Leishmaniasis
For cutaneous leishmaniasis, DNDi’s objective is to develop short, safe, efficacious, affordable, and field-adapted treatments, at least for lesions caused by L. tropica and L. braziliensis. As a short-term strategy, DNDi is developing a topical treatment based on amphotericin B, and aims to improve treatment strategies using currently available treatment modalities in combination.

In the medium to long term, DNDi aims to develop an oral drug and an immunemodulator for use in combination with chemotherapy. This novel approach aims to initially eliminate parasites with chemotherapy, followed by enhancement of the patient’s immune response with an immune-stimulating agent.

A new topical or oral treatment for cutaneous leishmaniasis would ideally be efficacious against all species, show at least 95% efficacy, be easy to use, short course (14-28 days), compatible for combination therapy, produce minimal scarring, be safe in pregnant and breastfeeding women, affordable and adapted to tropical climates.

By 2020, DNDi aims to deliver from its CL-specific portfolio:
- A safe, effective, and shorter-course treatment for cutaneous leishmaniasis

Population(s) Served

DNDi’s short-term goal was to make better use of existing treatments, for example through the development of a paediatric dosage form of benznidazole – a goal which was achieved in 2011. The treatment is registered in Brazil (2011), and was included on the WHO Essential Medicines List for children in 2013. An agreement signed in 2013 with the Mundo Sano Foundation will ensure a second source of the treatment previously solely manufactured by LAFEPE. Collaborative activities will continue to support country registration and adoption, and greater treatment availability to patients.

As a medium-term strategy, DNDi has been assessing known families of compounds such as the new azole antifungal drug, E1224, for activity against T. cruzi in adult chronic patients. Results from a proof-of-concept trial showed E1224 monotherapy to have some short-term effect on parasite clearance but with insufficient long-term efficacy, and the current regimen of benznidazole to be efficacious in the long term, but with side effects. Alternative benznidazole regimens, including reduced dosing and duration of treatment in monotherapy and combination treatment with E1224 are being explored. Fexinidazole, also in development for HAT and VL, is also being evaluated. Additionally, DNDi continues to search for potential biomarkers of treatment response to enhance clinical trial capabilities for evaluation of new compounds.

As part of its long-term strategy, DNDi continues to identify and engage partners from private and public sectors in order to identify, characterize, and advance the development of promising compounds as well as to pursue discovery efforts for innovative therapies.

In addition, DNDi supports clinical research capabilities and access through the Chagas Clinical Research Platform, which was launched in 2009.

Ideally, a new treatment would be for both acute and chronic phases of the disease, useful against most parasite species in all regions, with a better safety profile than existing drugs, non-inferior efficacy to benznidazole, easy-to-use (oral, once-a-day for less than 30 days, requiring no hospitalization and little or no monitoring), affordable, and adapted to tropical climates.

By 2020, DNDi aims to deliver from its Chagas-specific portfolio:
- An effective and safe new oral treatment regimen of chronic indeterminate Chagas disease, ideally also effective against the acute form of the disease
- Biomarkers to gain understanding of disease progression and ease the development of tools for evaluation of treatment response to support drug development

Population(s) Served

DNDi’s strategy is to develop a new compound with macrofilaricide activity for use as a safe and field-adapted macrofilaricidal drug for patient case management and possibly later MDA if needed.

As a medium-term strategy, DNDi is assessing emodepside, a potent antihelminthic drug used in combination with praziquantel to treat parasitic worms in cats and dogs, as a clinical candidate to treat humans.

As a long-term strategy, DNDi is assessing additional opportunities through an active screening programme of drug compounds emanating from animal health/ pharmaceutical companies and academic institutions, with the goal of selecting one or two candidates to move into clinical development.

Ideally a new treatment for adults and children will be a macrofilaricide (efficacious
against the adult form of worms), oral, short-course treatment, well tolerated, affordable, and adapted to tropical climates.

Population(s) Served

In 2010, DNDi was called on by various organizations, including Médecins Sans Frontières, WHO, and UNITAID, to apply its expertise to the development of paediatric HIV treatments. DNDi’s position, notably that paediatric HIV is a neglected disease, was published as a ‘Perspective’ in the New England Journal of Medicine in August 2011.

DNDi is pursuing two objectives to address the needs of HIV-infected children:
Develop and register two solid first-line 4-in-1 LPV/r-based fixed-dose combinations (FDCs) with two NRTIs. All components of the combination will be developed in the form of tastemasked granules, stable with no need for refrigeration, presented in a single unit with appropriate strengths to accommodate weight band dosing.
Develop and register a heat stable stand-alone ritonavir booster formulation that is well taste-masked and can be added to any PI-based paediatric ARV regimen and can be used to counteract the negative drug-drug interactions between PIs and rifampicin-containing TB treatments.

Before these formulations are made available however, as a short-term strategy, DNDi will start testing the use of PI-based treatment with existing LPV/r-based solid formulations before the availability of the 4-in-1 FDC, in order to provide better treatment for infants today and promote in-country adoption. The heat-stable pellets are already a great improvement, however the bitter taste remains and is a barrier to use in treating this chronic disease. DNDi participated in the CHAPAS-2 trial that compared LPV/r sprinkles (hereafter referred to as pellets) to the LPV/r liquid formulation. These pellets will be used in combination with NRTI dispersible tablets in implementation studies (LIVING Study).

In the longer-term, DNDi is working with its industrial partner, Cipla Ltd., on combining taste-masked LPV/r granules with two NRTIs into a single unit dose. This modular concept is flexible, so that any of the components can eventually be substituted to provide new fixed-dose combinations.

In addition, in order to address the needs of HIV/TB co-infected children, DNDi is developing a formulation of ritonavir for superboosting LPV/r at a 1:1 ratio. As a short-term strategy, DNDi is conducting a study to establish the pharmacokinetics, efficacy and safety of superboosted LPV/r in children in South Africa with the existing ritonavir solution.

The ideal first-line treatment for paediatric HIV would be a protease inhibitor-based all-in-one antiretroviral regimen for HIV-infected children which is a safe and efficacious, is an adapted formulation suitable for infants and children, is an easy-to-use fixed-dose combination, is palatable, addresses drug-drug interaction with medicines for tuberculosis, and is adapted to tropical climates (no refrigeration needed).

By 2019, DNDi aims to deliver from its paediatric HIV portfolio:
- Two new four-in-one paediatric formulations containing a PI (LPV/r) and two NRTIs (ABC or AZT and 3TC)
- One stand-alone paediatric booster RTV for HIV-TB co-infected children

Population(s) Served
Children and youth

Fosravucoazole (E1224) is a potent orally-available triazole which is under development for Chagas’ disease. Recent evidence suggests that it could be an effective treatment for fungal Mycetoma which would also be affordable. The efficacy of E1224 will be compared to the current treatment (itraconazole) in a randomized controlled clinical trial, examining its effect on moderate mycetoma lesions.

Population(s) Served

1. Regional R&D:
Short term (2 years) - Prove alternative regimens:
DNDi and partners aim to conduct Phase III clinical trials
proving the efficacy of sofosbuvir (SOF) + daclatasvir
(DCV) as a public health tool in Malaysia and Thailand.
Medium-term (5 years) - Developing a pipeline: License
most promising compounds from patent holders to
combine with other drugs to develop a novel regimen
for HCV to be used as a public health tool.

2. Support affordable access:
Create an actively engaged project Hep C Advisory
Group that can advise the project on the rapidlychanging
HCV treatment access landscape. The
group will be comprised of both Access and
Scientific experts. The project will be both informed
by and inform the project Hep C Advisory Group.
DNDi believes there are many avenues for access
including but not limited to: developing alternative
treatments with favorable licensing / access terms,
patent oppositions, compulsory licensing and
voluntary licensing.

Population(s) Served

The mission of the Global Antibiotic Research and Development Partnership (GARDP) is to develop new antibiotic treatments addressing antimicrobial resistance and to promote their responsible use for optimal conservation, while ensuring equitable access for all in need. GARDP is being incubated by the Drugs for Neglected Diseases initiative (DNDi) in collaboration with the World Health Organization (WHO) and in support of the Global Action Plan for Antimicrobial Resistance.

A partnership model for product development based on the experience gained from the field of neglected diseases can provide an important element of the overall strategy for R&D in the field of antibiotics. Such a partnership can test new incentives that also contribute to conservation of and access to new antibiotic treatments. By doing so, it can provide an important alternative to the traditional market-driven pharmaceutical approach, by focusing on products that the pharmaceutical industry will likely not develop for lack of profitability.

Launched in May 2016, GARDP is now in its incubation, or start-up phase, hosted by DNDi. This means that until the end of 2017, GARDP will build up its team, establish a legal entity, and set out its long-term strategy and roadmap. In addition, GARDP aims to have at least two projects that address urgent global health needs ready for implementation by the end of 2016, and two more by the end of 2017.

Population(s) Served

Where we work


Next Century Innovators Award 2013

Rockefeller Foundation

Goals & Strategy

SOURCE: Self-reported by organization

Learn about the organization's key goals, strategies, capabilities, and progress.

Charting impact

Four powerful questions that require reflection about what really matters - results.

DNDi maintains a steadfast commitment to deliver therapeutic solutions for diseases where innovation and access to safe, simple, effective, and affordable treatments are lacking. We aim tohave delivered 25 new treatments in our first 25 years.

We will leverage our rich portfolio of drug candidates and broad clinical networks for the NTDs and viral diseases we work on. We will continually assess new opportunities to address patients' unmet needs, exploring the feasibility and best pathways to address diseases with persistent R&D and access gaps, including for pandemic-prone and climate-sensitive diseases. We will foster sustainable solutions in close collaborations with LMIC partners, advance a proactive agenda for maternal and child health and gender-responsive R&D, champion open science and transparency, and advocate for change to support a more equitable R&D ecosystem that ensures access to innovation for all.

We use the power of innovation, open science, partnerships, and advocacy to find solutions to a great injustice: the lack of medicines for life-threatening diseases that disproportionately impact poor and marginalized people.

We innovate to save lives: We develop urgently needed treatments for neglected patients and work to ensure they’re affordable, available, and adapted to the communities who need them.

We foster inclusive and sustainable solutions: We work hand in hand with partners in low- and middle-income
countries to power our progress and strengthen innovation ecosystems that put people’s needs first.

We advocate for change: We speak out for policy change to enable more effective and equitable R&D and access to the fruits of science for all people in need, no matter their income or where they live.

None of the organization's work is possible without the passionate, motivated, and diverse people, spanning public, private, and non-governmental sectors. The people and partners behind the success of DNDi worldwide embody the organization's values in its patient-driven approach, best science and quality for the most neglected, commitment to building partnerships, pragmatism and responsibility, and spirit of entrepreneurship and innovation.

Achievements since 2003:
-12 field-adapted and affordable treatments* delivered for six deadly diseases
-4 clinical research networks created for leishmaniasis, sleeping sickness, and Chagas disease bringing together 500+ medical and research experts worldwide
-Clinical Research Coalition established for COVID-19 with 900+ members from nearly 100 countries
-Over 7,250 people trained in clinical trial management
-R&D alliances developed with 200+ public and private partners in 40+ countries delivering the best science for the most neglected
-Diverse global team of 230+ staff driving research, partnerships, and advocacy across 9 organizational hubs worldwide
-EUR 767.5 million funding secured to deliver on our mission in addition to EUR 83 million in-kind contributions and collaborative funding
-New organization created with WHO to fight drug-resistant infections: the Global Antibiotic R&D Partnership (GARDP), now an independent organization

How we listen

SOURCE: Self-reported by organization

Seeking feedback from people served makes programs more responsive and effective. Here’s how this organization is listening.

done We shared information about our current feedback practices.
  • How is your organization using feedback from the people you serve?

    To identify and remedy poor client service experiences, To identify bright spots and enhance positive service experiences, To strengthen relationships with the people we serve

  • Which of the following feedback practices does your organization routinely carry out?

  • What challenges does the organization face when collecting feedback?


Drugs for Neglected Diseases Initiative, North America Inc.

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The people, governance practices, and partners that make the organization tick.


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Connect with nonprofit leaders


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Drugs for Neglected Diseases Initiative, North America Inc.

Board of directors
as of 06/08/2023
SOURCE: Self-reported by organization
Board chair

Darin Portnoy

Family Medicine Attending/Teaching Faculty, Residency Program in Family and Social Medicine, Montefiore Medical Center; former President, Doctors Without Borders USA

Term: 2019 -

John Lawrence

President, Médecins Sans Frontières (MSF) USA; Staff Pediatric Surgeon, Maimonides Medical Center

Meena Ahamed

Advisory Board Member, Médecins Sans Frontières (MSF) USA

Kristina Torgeson

President, Board of Directors, The Alliance for International Medical Action (ALIMA) USA; former Secretary General, Doctors Without Borders/Médecins Sans Frontières (MSF) International

Bernard Pécoul

Executive Director, DNDi

Shing Chang

Independent Consultant, global health-related drug discovery and development; former Research & Development Director, DNDi

Bennett Shapiro

Partner, PureTech Ventures; former Executive Vice President, Merck

Africa Stewart

President, Médecins Sans Frontières (MSF) USA

Darin Portnoy

Family Medicine Attending/Teaching Faculty, Residency Program in Family and Social Medicine, Montefiore Medical Center; former President, Doctors Without Borders USA

Board leadership practices

SOURCE: Self-reported by organization

GuideStar worked with BoardSource, the national leader in nonprofit board leadership and governance, to create this section.

  • Board orientation and education
    Does the board conduct a formal orientation for new board members and require all board members to sign a written agreement regarding their roles, responsibilities, and expectations? No
  • CEO oversight
    Has the board conducted a formal, written assessment of the chief executive within the past year ? No
  • Ethics and transparency
    Have the board and senior staff reviewed the conflict-of-interest policy and completed and signed disclosure statements in the past year? Yes
  • Board composition
    Does the board ensure an inclusive board member recruitment process that results in diversity of thought and leadership? Yes
  • Board performance
    Has the board conducted a formal, written self-assessment of its performance within the past three years? No

Organizational demographics

SOURCE: Self-reported; last updated 3/8/2023

Who works and leads organizations that serve our diverse communities? Candid partnered with CHANGE Philanthropy on this demographic section.


No data

Race & ethnicity

Gender identity

Transgender Identity

Sexual orientation


We do not display disability information for organizations with fewer than 15 staff.

Equity strategies

Last updated: 03/06/2023

GuideStar partnered with Equity in the Center - an organization that works to shift mindsets, practices, and systems to increase racial equity - to create this section. Learn more

  • We have long-term strategic plans and measurable goals for creating a culture such that one’s race identity has no influence on how they fare within the organization.
Policies and processes
  • We use a vetting process to identify vendors and partners that share our commitment to race equity.
  • We seek individuals from various race backgrounds for board and executive director/CEO positions within our organization.
  • We help senior leadership understand how to be inclusive leaders with learning approaches that emphasize reflection, iteration, and adaptability.
  • We engage everyone, from the board to staff levels of the organization, in race equity work and ensure that individuals understand their roles in creating culture such that one’s race identity has no influence on how they fare within the organization.