• DNDi_Logo_No-Tagline_Full Colour
  • Our work
    • Diseases
      • Sleeping sickness
      • Visceral leishmaniasis
      • Cutaneous leishmaniasis
      • Chagas disease
      • Filaria: river blindness
      • Mycetoma
      • Paediatric HIV
      • Cryptococcal meningitis
      • Hepatitis C
      • Dengue
      • Pandemic preparedness
      • Antimicrobial resistance
    • Research & development
      • R&D portfolio & list of projects
      • Drug discovery
      • Translational research
      • Clinical trials
      • Registration & access
      • Treatments delivered
    • Advocacy
      • Open and collaborative R&D
      • Transparency of R&D costs
      • Pro-access policies and IP
      • Children’s health
      • Gender equity
      • Climate change
      • AI and new technologies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • Dengue Alliance
      • HAT Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Switzerland
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia
      • DNDi South-East Asia
  • News & resources
    • News & stories
      • News
      • Stories
      • Statements
      • Viewpoints
      • Social media
      • eNews Newsletter
    • Press
      • Press releases
      • In the media
      • Podcasts, radio & TV
    • Resources
      • Scientific articles
      • Our publications
      • Videos
    • Events
  • About us
    • About
      • Who we are
      • How we work
      • Our strategy
      • Our donors
      • Annual reports
      • Our prizes and awards
      • Our story: 20 years of DNDi
    • Our people
      • Our leadership
      • Our governance
      • Contact us
    • Work with us
      • Working at DNDi
      • Job opportunities
      • Requests for proposal
  • Donate
  • DNDi_Logo_No-Tagline_Full Colour
  • Our work
    • Diseases
      • Sleeping sickness
      • Visceral leishmaniasis
      • Cutaneous leishmaniasis
      • Chagas disease
      • Filaria: river blindness
      • Mycetoma
      • Paediatric HIV
      • Cryptococcal meningitis
      • Hepatitis C
      • Dengue
      • Pandemic preparedness
      • Antimicrobial resistance
    • Research & development
      • R&D portfolio & list of projects
      • Drug discovery
      • Translational research
      • Clinical trials
      • Registration & access
      • Treatments delivered
    • Advocacy
      • Open and collaborative R&D
      • Transparency of R&D costs
      • Pro-access policies and IP
      • Children’s health
      • Gender equity
      • Climate change
      • AI and new technologies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • Dengue Alliance
      • HAT Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Switzerland
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia
      • DNDi South-East Asia
  • News & resources
    • News & stories
      • News
      • Stories
      • Statements
      • Viewpoints
      • Social media
      • eNews Newsletter
    • Press
      • Press releases
      • In the media
      • Podcasts, radio & TV
    • Resources
      • Scientific articles
      • Our publications
      • Videos
    • Events
  • About us
    • About
      • Who we are
      • How we work
      • Our strategy
      • Our donors
      • Annual reports
      • Our prizes and awards
      • Our story: 20 years of DNDi
    • Our people
      • Our leadership
      • Our governance
      • Contact us
    • Work with us
      • Working at DNDi
      • Job opportunities
      • Requests for proposal
  • Donate
Home > Research and development > Portfolio

Visceral leishmaniasis 

New VL treatments (South Asia)

Home > Research and development > Portfolio

Visceral leishmaniasis

New VL treatments (South Asia)

objective

Develop short-course treatments for visceral leishmaniasis in South Asia to replace treatments with severe side effects and growing drug resistance

project start
2006
project status
Treatment delivered in 2011

current phase of drug development

Discovery project phase
Drug Discovery
Translation project phase
Translational research
clinical trials icon
Clinical trials
Treatment Access
Registration & access

updated 24 Feb 2025

Adoption of new visceral leishmaniasis treatments in South Asia  

Policy change for control and elimination of visceral leishmaniasis brings better treatments to patients in Bangladesh, India, and Nepal

In the early 21st century, treatments for visceral leishmaniasis (also known as kala-azar) in South Asia were difficult for patients to take or growing ineffective. Resistance was increasing, including to the oral drug miltefosine. Antimonials such as sodium stibogluconate had lengthy treatment times, difficult treatment administration, and poor tolerability that caused frequent side effects.

In 2010, WHO recommended using new short-course treatments for visceral leishmaniasis in South Asia based on excellent results in Phase III studies. However, more evidence was needed on the safety and effectiveness of using these treatments for in wider populations under field conditions.

DNDi convened a consortium of partners to identify the best combination therapies for South Asia. The consortium conducted a four year-long implementation study in Bangladesh and India (2012 – 2015) to assess the safety, efficacy, and patient adherence of three new treatment options: single-dose liposomal amphotericin B; a paromomycin and miltefosine combination; and a single-dose liposomal amphotericin B and miltefosine combination. The results showed that these treatments are safe and effective, with cure rates above 95%. They also shorten the length of treatment, reduce the risk of resistance, and allow treatment of patients closer to their homes, making it easier for people to complete the full treatment course.

The research provided key evidence for policy changes by the Bangladeshi, Indian, and Nepali Ministries of Health, which made the following recommendations: single-dose liposomal amphotericin B as the first option for treatment of visceral leishmaniasis, and a combination of paromomycin and miltefosine as the second option.

Ambisome treatment

Treatment regimens

  • Indication: Visceral leishmaniasis in Asia
  • Dosage: First option: single-dose liposomal amphotericin B given as an intravenous infusion; Second option: paromomycin and miltefosine, both daily for 10 days

Impact

  • Treatments recommended by WHO Expert Committee on the Control of Leishmaniases in 2010 as safe and effective treatments for visceral leishmaniasis in Asia (liposomal amphotericin B single or multiple dose, and all combinations tested in DNDi’s clinical trial) 
  • Supported policy change for the control and elimination of visceral leishmaniasis in highly endemic countries: Bangladesh, India, and Nepal 
  • Result of partnership in India with the Bihar State Health Society, GVK Biosciences, Indian Council of Medical Research, Kala Azar Medical Research Centre, Médecins Sans Frontières, National Vector Borne Disease Control Programme, and Rajendra Memorial Research Institute of Medical Sciences 
  • Result of partnership in Bangladesh with the International Centre for Diarrhoeal Disease Research, Médecins Sans Frontières, Ministry of Health and Family Welfare, Shaheed Suhrawardy Medical College and Hospital 

‘Earlier the ward used to be full of visceral leishmaniasis patients because of the long 28-day treatment. But since single-dose liposomal amphotericin B has been included in the national treatment protocol, the face of the disease has changed dramatically. Now patients come, take treatment, and go home the same day. This is an effective treatment, and now with this the number of patients have come down.’

Nutan Kumari, Sadar Hospital in Hajipur, Bihar  

Project updates

2024

Following the recommendation of the World Health Organization mission on the kala-azar elimination programme in 2019, DNDi partnered with the India Ministry of Health and ICMR RMRI to establish a reference Centre of Excellence for the management of patients with leishmaniasis to bring diagnostic and treatment facilities closer to affected communities, build health provider expertise, and give effect to new guidelines for the treatment of visceral leishmaniasis and post-kala-azar dermal leishmaniasis (PKDL). In collaboration with the Ministry of Health of Bangladesh, the successful model was expanded to the country with the establishment of a Centre of Excellence at the Infectious Diseases Hospital, Dhaka in 2024 with the aim of building on the country’s success in eliminating VL as a public health problem and achieving zero new cases and zero transmission by 2030. With support from DNDi, the Centre of Excellence hosted a two-day training in April to enhance the clinical skills of frontline doctors, nurses, and laboratory technicians in visceral leishmaniasis and PKDL diagnosis and treatment. This included advanced laboratory techniques and emerging diagnostic and treatment protocols that will contribute to strengthening national efforts to reach its 2030 goals. Preparations to establish a Centre of Excellence in Nepal are ongoing.

2023

In October 2023, the World Health Organization announced that Bangladesh has eliminated visceral leishmaniasis as a public health problem – the first country in the world to achieve elimination status, reporting fewer than 1 case per 10,000 people over three consecutive years. Research conducted by DNDi and partners from 2012-2015 provided key evidence to support visceral leishmaniasis treatment policy change in Bangladesh, India, and Nepal, including the recommendation of single-dose liposomal amphotericin B as the first treatment option and a combination of paromomycin and miltefosine as the second option. The new options shortened the length of treatment, reduced the risk of resistance, and made it easier for people to complete their full course of treatment.

2021

To overcome the limitations of current treatment regimens and contribute to the sustainable elimination of visceral leishmaniasis in South Asia, DNDi aims to deliver a safe, highly effective oral therapy for children and adults that can be deployed at all levels of the health system. A dossier to conduct a Phase II clinical trial on LXE408, a new chemical entity selected and nominated by the DNDi Scientific Advisory Committee as a clinical candidate, was submitted to Indian Regulatory Authorities in August 2021. 

2018

In 2010, WHO recommended the use of new short-course treatment regimens for VL in South Asia. Although Phase III studies have shown excellent results, there was a lack of evidence on a wider treatment population, and on the safety and effectiveness of these regimens under field conditions. From 2012 to 2016, DNDi and partners conducted a pilot study in Bihar, India on three regimens (including new combination therapies (single dose liposomal amphotericin B, a combination of miltefosine and paromomycin (AmB+PM), and a combination of liposomal amphotericin B and miltefosine (AmB+Milt)) in 1761 patients. All regimens showed acceptable outcomes and safety profiles under field conditions. Cure rates were: for SDA 95.5%, AmB+Milt 95.5% and AmB+PM 99.6%. These results contributed to national treatment policy change in India, Bangladesh, and Nepal.

2017

Following a 2016 pilot study in Bihar, India on three regimens (including new combination therapies (single dose liposomal amphotericin B (SDA), a combination of miltefosine and paromomycin, and a combination of liposomal amphotericin B and miltefosine) whose results contributed to a change in the national treatment guidelines in India, a follow-up protocol was developed for a cohort observational study to estimate the incidence of post-kala-azar dermal leishmaniasis (PKDL) during or more than 24 months post-treatment in VL patients treated with any of the three regimens. Enrolment started in June 2016, and by the end of 2017, recruitment was completed with 1622 participants assessed (representing 92% of the VL patients treated in the India implementation study). Preliminary results show that PKDL was observed in 3.6% of patients at least 24 months after treatment of VL. Further analysis is ongoing.

2016

In India, DNDi continues to support the rolling out of treatments as per the Indian National Kala-Azar Elimination Roadmap, after data from a DNDi implementation study contributed to a change in the national guidelines, which now recommend the use of single-dose liposomal amphotericin B in areas of high prevalence, and paromomycin/miltefosine combination in low-prevalence districts.

2015

In Asia, DNDi and partners, working closely with the Indian government, have provided data from an implementation study (1761 enrolled patients) to support policy change expressed in the revised National Kala-Azar Elimination Roadmap, which recommends the use of liposomal amphotericin B single infusion in areas of high prevalence and paromomycin/miltefosine combination as appropriate in low prevalence districts. Follow-up visits continue to assess long-term efficacy and identify development of PKDL.

News & resources

  • 25 February 2025 – Patient insights research exploring disease awareness, patient life experience, and current management of visceral leishmaniasis in Bihar, India, PLOS Neglected Tropical Diseases
  • 26 September 2019 – Field effectiveness of new visceral leishmaniasis regimens after 1 year following treatment within public health facilities in Bihar, India, PLOS Neglected Tropical Diseases
  • 22 October 2018 – Field safety and effectiveness of new visceral leishmaniasis treatment regimens within public health facilities in Bihar, India, PLOS Neglected Tropical Diseases
  • 12 June 2017 – Safety and efficacy of short course combination regimens with AmBisome®, miltefosine, paromomycin for the treatment of visceral leishmaniasis (VL) in Bangladesh, PLOS Neglected Tropical Diseases
  • 26 January 2017 – Investments in research and surveillance are needed to go beyond elimination and stop transmission of Leishmania in the Indian subcontinent, PLOS Negl Trop Dis
  • 21 August 2014 – How far are we from visceral leishmaniasis elimination in Bangladesh? An assessment of epidemiological surveillance data, PLOS NTDs
  • 1 January 2011 – Comparison of short-course multidrug treatment with standard therapy for visceral leishmaniasis in India: an open-label, non-inferiority, randomised controlled trial, The Lancet

Partners

  • Indian Council of Medical Research, India
  • International Centre for Diarrhoeal Disease Research (ICDDR), Bangladesh
  • Kala Azar Medical Research Centre, India
  • London School of Hygiene & Tropical Medicine (LSHTM), UK
  • Ministry of Health and Family Welfare Bangladesh, Bangladesh
  • Médecins Sans Frontières (MSF) Spain, Spain
  • National Vector Borne Disease Control Programme, India, India
  • OneWorld Health (OWH), USA
  • PATH, USA
  • Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), India
  • Shaheed Suhrawardy Medical College and Hospital, Bangladesh
  • State Health Society, Bihar, India
  • WHO-TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland
Loading…
  • Indian Council of Medical Research
  • ,India
  • International Centre for Diarrhoeal Disease Research (ICDDR)
  • ,Bangladesh
  • Kala Azar Medical Research Centre
  • ,India
  • London School of Hygiene & Tropical Medicine (LSHTM)
  • ,UK
  • Médecins Sans Frontières (MSF) Spain
  • ,Spain
  • Ministry of Health and Family Welfare Bangladesh
  • ,Bangladesh
  • National Vector Borne Disease Control Programme, India
  • ,India
  • OneWorld Health (OWH)
  • ,USA
  • PATH
  • ,USA
  • Rajendra Memorial Research Institute of Medical Sciences (RMRIMS)
  • ,India
  • Shaheed Suhrawardy Medical College and Hospital
  • ,Bangladesh
  • State Health Society, Bihar
  • ,India
  • WHO-TDR, Special Programme for Research and Training in Tropical Diseases
  • ,Switzerland
  • State Health Society, Bihar, India
  • Indian Council of Medical Research, India
  • International Centre for Diarrhoeal Disease Research (ICDDR), Bangladesh
  • Kala Azar Medical Research Centre, India
  • London School of Hygiene & Tropical Medicine (LSHTM), UK
  • Médecins Sans Frontières (MSF) Spain, Spain
  • Ministry of Health and Family Welfare Bangladesh, Bangladesh
  • National Vector Borne Disease Control Programme, India, India
  • OneWorld Health (OWH), USA
  • PATH, USA
  • Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), India
  • Shaheed Suhrawardy Medical College and Hospital, Bangladesh
  • WHO-TDR, Special Programme for Research and Training in Tropical Diseases, Switzerland

Funding

  • Germany - Federal Ministry for Economic Cooperation and Development (BMZ) through KfW
  • Spain - Spanish Agency for International Development Cooperation (AECID)
  • Switzerland - Swiss Agency for Development and Cooperation (SDC)
  • UK - UK International Development
​
  • Gates Foundation
  • Médecins Sans Frontières International
  • Other private foundations and individuals
​

Stay connected

Get our latest news, personal stories, research articles, and job opportunities. 

Linkedin-in Instagram Twitter Facebook-f Youtube
International non-profit developing safe, effective, and affordable treatments for the most neglected patients.

Learn more

  • Diseases
  • Neglected tropical diseases
  • R&D portfolio
  • Policy advocacy

Get in touch

  • Our offices
  • Contact us
  • Integrity Line

Support us

  • Donate
  • Subscribe to eNews

Work with us

  • Join research networks
  • Jobs
  • RFPs
  • Terms of Use   
  •   Acceptable Use Policy   
  •   Privacy Policy   
  •   Cookie Policy   
  •   Our policies   

  • Except for images, films and trademarks which are subject to DNDi’s Terms of Use, content on this site is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 3.0 Switzerland License