Leishmaniasis - Pipeline Insight, 2025

This “Leishmaniasis - Pipeline Insight, 2025” report provides comprehensive insights about 4+ companies and 4+ pipeline drugs in Leishmaniasis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Leishmaniasis: Understanding

Leishmaniasis: Overview

Leishmaniasis is a complex and diverse parasitic disease caused by over 20 species of the Leishmania parasite, which is transmitted to humans through the bites of infected female phlebotomine sandflies. The disease manifests in three primary forms: cutaneous, mucocutaneous, and visceral leishmaniasis, each varying significantly in symptoms, severity, and geographical distribution. Cutaneous leishmaniasis, the most common form, presents as ulcerative skin lesions that can result in significant scarring and disfigurement. Mucocutaneous leishmaniasis, though less common, can cause severe damage to mucous membranes in the nose, mouth, and throat, leading to disfigurement and functional impairment if not treated. Visceral leishmaniasis, the most severe form, affects internal organs such as the spleen, liver, and bone marrow, and can be fatal if untreated. It is characterized by prolonged fever, weight loss, anemia, and hepatosplenomegaly (enlargement of the liver and spleen).

The epidemiology of leishmaniasis is closely tied to environmental factors, socio-economic conditions, and human activities that influence the distribution of the sandfly vector. The disease is endemic in parts of Asia, Africa, the Middle East, Latin America, and southern Europe, with approximately 700,000 to 1 million new cases reported annually. Factors such as deforestation, urbanization, migration, and climate change contribute to the spread of the disease by altering sandfly habitats and increasing human-vector contact. The disease disproportionately affects impoverished populations living in remote areas with limited access to healthcare, making it a significant public health concern. In recent years, there has been an increase in cases of leishmaniasis linked to human-induced environmental changes and conflict zones, further complicating control efforts.

Diagnosis of leishmaniasis depends on the clinical form of the disease and typically involves a combination of clinical assessment, parasitological tests (such as microscopy or culture of tissue samples), and molecular techniques like polymerase chain reaction (PCR). Serological tests are also used, particularly for visceral leishmaniasis, where detecting the parasite in internal organs is challenging. Treatment options vary depending on the form of the disease, the Leishmania species involved, and the patient's immune status. First-line treatments include pentavalent antimonials, amphotericin B, miltefosine, and paromomycin. However, treatment can be complicated by drug resistance, side effects, and the need for prolonged courses of therapy. Prevention strategies focus on vector control through insecticide spraying, use of insecticide-treated bed nets, and environmental management to reduce sandfly breeding sites. Despite ongoing research, there is currently no effective vaccine for leishmaniasis, making prevention and early treatment critical to managing the disease.

'Leishmaniasis- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Leishmaniasis pipeline landscape is provided which includes the disease overview and Leishmaniasis treatment guidelines. The assessment part of the report embraces, in depth Leishmaniasis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Leishmaniasis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Leishmaniasis R&D. The therapies under development are focused on novel approaches to treat/improve Leishmaniasis.

Leishmaniasis Emerging Drugs Chapters

This segment of the Leishmaniasis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Leishmaniasis Emerging Drugs

LXE408: Novartis Pharmaceuticals

LXE408 is a first-in-class parasite-selective inhibitor of the kinetoplastid proteasome with potent and uniform anti-parasitic activity against all kinetoplastid parasites, including Leishmania species causing visceral leishmaniasis (L. donovani and L. infantum), as well as parasites causing Chagas disease (T. cruzi) and human African trypanosomiasis (T. brucei). Safety data in healthy volunteers suggest that LXE408 is safe and tolerated at all doses tested (up to 600 mg single dose and 600 mg multiple dose). Currently, the drug is in the Phase II stage of development to treat Visceral Leishmaniasis.

Leishmaniasis: Therapeutic Assessment

This segment of the report provides insights about the different Leishmaniasis drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Leishmaniasis

• There are approx. 4+ key companies which are developing the therapies for Leishmaniasis. The companies which have their Leishmaniasis drug candidates in the most advanced stage, i.e. Phase II include, Novartis Pharmaceuticals.

Phases

The report covers around 4+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Leishmaniasis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Leishmaniasis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Leishmaniasis therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Leishmaniasis drugs.

Leishmaniasis Report Insights

• Leishmaniasis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Leishmaniasis Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Leishmaniasis drugs?
• How many Leishmaniasis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Leishmaniasis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Leishmaniasis therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Leishmaniasis and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• GlaxoSmithKline
• Novartis Pharmaceuticals

Key Products

• GSK3494245
• LXE408

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