• 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 > Diseases
leishmaniasis icon

Cutaneous leishmaniasis

Target product profile for cutaneous leishmaniasis

Home > Diseases
leishmaniasis icon

Cutaneous leishmaniasis

Target product profile for cutaneous leishmaniasis

  • Overview
  • Facts
  • Projects & achievements
  • Target product profiles

DNDi aims to develop a topical or oral treatment for all species of leishmania causing cutaneous or mucocutaneous leishmaniasis that is safe and effective for all patients and does not require a cold chain.

Target product profile for cutaneous leishmaniasis

IdealAcceptable
Target speciesOne treatment for all species of Leishmania L. tropica or L. braziliensis
Safety/tolerabilityWell tolerated
All adverse reactions (AR)s ≤ grade 1
Safety monitoring at primary health care (PHC) level.
No major safety concerns:
Well tolerated in >95% of patients treated.
Systemic AR ≤ Grade 3 in <5%.
Local AR ≤ grade 2 in <30%
No treatment-induced mortality
ContraindicationsNoneCan be assessed at primary health care level.
Efficacy>95% patients with complete clinical cure, defined as 100% epithelialization/flattening of lesion(s) at 3 months from treatment onset

Minimal scar
No relapse or development of Leishmania recidivans or mucocutaneous leishmaniasis (MCL)
Parasitological endpoint not required
60% epithelialization/flattening of lesion(s) for L. tropica and 70% for L. braziliensis patients with complete cure

Scar no worse than natural healing
<5% rate of relapse or development of Leishmania recidivans or MCL at 1 year
FormulationTopical / oral Non-parenteral,
or few doses if parenteral
Treatment regimenTopical ≤ 14 days
Oral < 7 days
Topical: 28 days
Oral: twice daily for 28 days
Parenteral ≤ 3 injections
Target populationNo restrictions>9 months of age
No efficacy in immune-compromised patients
Not for use in pregnancy (category B*)
StabilityNo cold chain
At least 3 years at 37º C
2 years at 4-8º C
CostTo be definedTo be defined

* No signs of risk in animal studies, but no adequate studies in humans

Making medical history for neglected patients

We develop urgently needed treatments for neglected patients and ensure they’re affordable, available, and adapted to the communities who need them

Young boy sitting on a hospital bed being examined by a nurse

Chagas disease

Causes heart and vital organ damage, after people are bitten by blood-sucking bugs

We delivered the first-ever treatment for children; now we’re searching for new drug candidates and working to boost access to care

Patient medical examination

Cryptococcal meningitis

Without treatment, deadly for thousands of people with advanced HIV

We’re working to improve access to life-saving treatments and developing an easier-to-use formulation

Girl with skin lesions on her nose

Cutaneous leishmaniasis

Leaves disfiguring, life-long scars that lead to severe social stigma

We’re working to develop safer, shorter treatments for this disabling disease

Doctor with young patient in hospital setting

Dengue

Rapidly spreading climate-sensitive disease with no specific treatment

We’re building a global partnership with dengue-endemic countries to develop a first treatment

Father walking in rural village with a cane and holding his son's hand

Filaria: river blindness

Lead to unbearable itching, disfiguring skin lesions, and even blindness

We’re working to develop a safe, effective, and affordable drug for the prevention and treatment of this debilitating disease

Young man standing in the street

Hepatitis C

Millions are left without treatment even though effective drugs exist

We’ve delivered a treatment as simple, safe, and effective as the best drugs available today – at a fraction of the cost 

Woman standing in front of her door house in a rural village in Sudan

Mycetoma

Often ends in amputation​, after people get infected from stepping on a thorn

We conducted the world’s first trial for an alternative to current treatments, which are toxic and difficult to administer

Mother holding her baby in her arms smiling

Paediatric HIV

Without treatment, half of children die before their second birthday

We’ve developed a strawberry-flavoured treatment to meet the needs of children long neglected by the global HIV response

Healthcare workers in a hospital

Pandemic Preparedness

The COVID-19 pandemic intensified global health inequalities

We’re bringing together partners and accelerating research to prepare for future viral pandemics in low-resource settings

Doctor diagnosing a man in a village with his hands on the man's neck

Sleeping sickness

Transmitted by the bite of a tsetse fly and causes severe neurological disorders

We delivered a revolutionary new drug to replace toxic treatments, and have ongoing trials to eliminate this disease

Girl looking over a fence

Visceral leishmaniasis

Is one of the world’s biggest parasitic killers, spread by the bites of sandflies

We’re working to develop a new generation of treatments to replace drugs that are painful, ineffective, and cause side effects

Chagas disease

Cryptococcal meningitis

Cutaneous leishmaniasis

Dengue

Filaria: river blindness

Hepatitis C

Mycetoma

Paediatric HIV

Pandemic Preparedness

Sleeping sickness

Visceral leishmaniasis

VIEW ALL DISEASES

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