Leishmaniasis Advocacy Hub | UniteRare

At a Glance

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Regulatory Watchboard

10 events

Jan 2027Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL)

Institute of Tropical Medicine, Belgium — PHASE3

TrialNOT YET RECRUITING

Jan 2026Pilot Study: Miltefosine Gel (G-MTF) in Patients With Cutaneous Leishmaniasis

Universidad Industrial de Santander — PHASE1

TrialNOT YET RECRUITING

Nov 2025A Clinical Trial to Investigate Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Oral Regimens and Oral Miltefosine as Active Control in Participants Aged ≥ 18 Years Old With Localized Cutaneous Leishmaniasis in the Region of the Americas (AMR).

Drugs for Neglected Diseases — PHASE2

TrialNOT YET RECRUITING

Oct 2025Recurrent Visceral Leishmaniasis in HIV Co-Infection

Institute of Tropical Medicine, Belgium

TrialRECRUITING

Oct 2025Arnica Tincture Fot the Treatment of Cutaneous Leishmaniasis II.

Universidad de Antioquia — PHASE3

TrialNOT YET RECRUITING

May 2025Human Bioequivalence Study of Liposomal Amphotericin B for Injection

Sichuan Huiyu Pharmaceutical Co., Ltd — NA

TrialACTIVE NOT RECRUITING

Apr 2025Antimicrobial Adjuvants to Revert the Imbalance of Skin Microbiota for Improved Outcomes of Complicated Cutaneous Leishmaniasis Treatment in Ethiopia

Institute of Tropical Medicine, Belgium — PHASE3

TrialNOT YET RECRUITING

Feb 2025Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis

Hayder Adnan Fawzi — PHASE2

TrialRECRUITING

Feb 2025Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis

Hayder Adnan Fawzi — PHASE2

TrialRECRUITING

Feb 2025Ciprofloxacin Intralesional Injection for the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate

Al-Mustafa University College — PHASE2

TrialRECRUITING

Data from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Financial Assistance

1 program

FINANCIAL LANDSCAPE SUMMARY

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IMPAVIDO

Profounda

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Approved Treatments

1 FDA-approved

IMPAVIDO

(miltefosine)Orphan drug

Knight Therapeutics (USA)

Antileishmanial [EPC]

12.1 Mechanism of Action Miltefosine is an anti-leishmanial agent [see Clinical Pharmacology ( 12.4 )] .

Approved Mar 2014FDA label ↗

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Clinical Trial Landscape

18 active trials

1Phase 3

6Phase 2

1Phase 1

2N/A

7Unknown

1PHASE2, PHASE3

18Total recruiting

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Recent News & Research

No recent news articles indexed yet for Leishmaniasis.
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Specialist Network

Top 6 by expertise

Shyam Sundar, MD

Banaras Hindu University

Score 368 trials

Wim Adriaensen, PhD

Institute of Tropical Medicine Antwerp

Score 321 trial

Dinesh Mondal, PhD

Senior Scientist

Score 321 trial

Jane Mbui, MD

Kenya Medical Research Institute

Score 321 trial

Rezika Mohammed, MD

University Hospital of Gondar, Ethiopia

Score 311 trial

J Soto, MD

FADER

Score 301 trial

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