mycosis fungoides pipeline insight

DelveInsight’s, “Mycosis Fungoides - Pipeline Insight, 2025” report provides comprehensive insights about 4+ companies and 6+ pipeline drugs in Mycosis Fungoides 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.

Geography Covered

• Global coverage

Mycosis Fungoides: Understanding

Mycosis Fungoides: Overview

Mycosis fungoides (MF) is the most common subtype of cutaneous T-cell lymphoma (CTCL), a heterogeneous group of extranodal non-Hodgkin lymphomas that primarily involve the skin without initial systemic involvement. MF originates from peripheral epidermotropic memory T-cells, typically characterized by a CD4+ immunophenotype and expression of the T-cell receptor (TCR). Clinically, MF presents with a slow progression through distinct stages—beginning with flat, scaly patches, advancing to thicker plaques, and eventually forming nodular or tumor-like lesions. These lesions often appear on sun-protected areas of the body such as the trunk, buttocks, and thighs. Despite sometimes sharing histological features with systemic lymphomas, MF behaves differently and usually follows an indolent course in its early stages. However, in some cases, it can progress to more aggressive disease with systemic dissemination, requiring more intensive treatment. Early diagnosis and stage-appropriate management are crucial to improving patient outcomes and quality of life.

The clinical presentation of Mycosis fungoides (MF) typically progresses through several stages, beginning with the premycotic phase, characterized by a persistent, scaly red rash on sun-protected areas of the skin, often lasting for months or years. This is followed by the patch phase, where thin, reddened, eczema-like patches resembling plaque parapsoriasis develop. As the disease advances, the plaque phase emerges with thicker, raised lesions that are more infiltrated and may become scaly or itchy. In the tumor phase, nodular tumors appear on the skin, which may ulcerate and become prone to infection. In more severe and widespread cases, erythroderma may occur, involving generalized redness and scaling of the skin, often associated with Sézary syndrome. Additional features can include hypopigmented patches, hair loss (alopecia), skin erosions, bullous lesions, dry scaling, and lymphadenopathy, reflecting the variable and progressive nature of MF.

Among cutaneous lymphomas, approximately two-thirds are of T-cell origin, with the most common immunophenotype being CD4-positive. In Mycosis fungoides (MF), there is a clonal proliferation of CD4+ T-cells that frequently lack normal T-cell surface antigens such as CD7, CD5, or CD2, indicating their malignant transformation. These atypical T-cells are attracted to the skin by signals from keratinocytes and accumulate in the dermis, where they often cluster around Langerhans cells to form characteristic structures known as Pautrier microabscesses. Some malignant cells may migrate to regional lymph nodes and eventually enter the bloodstream, circulating with other cutaneous lymphocyte antigen (CLA)-positive T-cells, contributing to systemic involvement in advanced stages.

Treatment of Mycosis fungoides (MF) is stage-dependent. In early stages (IIA or below), skin-directed therapies such as topical corticosteroids, nitrogen mustard, bexarotene, imiquimod, PUVA, or UVB are commonly used, with localized radiation for isolated lesions. For widespread or symptomatic plaques, total skin electron beam therapy (TSEBT) or a combination of skin-directed and systemic therapies is preferred. Systemic options like retinoids, interferons, HDAC inhibitors, or methotrexate are used for more severe or refractory cases. In advanced stages (IIB–IV), treatment aims at disease control and symptom relief, using TSEBT, systemic therapies, or combined approaches. Allogeneic stem cell transplantation may be considered in resistant or aggressive cases.

"Mycosis Fungoides- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Mycosis Fungoides pipeline landscape is provided which includes the disease overview and Mycosis Fungoides treatment guidelines. The assessment part of the report embraces, in depth Mycosis Fungoides 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, Mycosis Fungoides 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 Mycosis Fungoides R&D. The therapies under development are focused on novel approaches to treat/improve Mycosis Fungoides.

Mycosis Fungoides Emerging Drugs Chapters

This segment of the Mycosis Fungoides 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.

Mycosis Fungoides Emerging Drugs

• Hypericin: Soligenix

HyBryte™ (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by safe, visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. Currently, the drug is in Phase III stage of its development for the treatment of Mycosis Fungoides.

• IPH4102: Innate Pharma

Lacutamab (IPH4102) is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody, which is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Lacutamab has been granted U.S. FDA Breakthrough Therapy Designation for relapsed or refractory Sézary syndrome. Innate Pharma SA announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to lacutamab, an anti-KIR3DL2 cytotoxicity-inducing antibody, for the treatment of adult patients with relapsed or refractory (r/r) Sézary syndrome (SS) after at least 2 prior systemic therapies including mogamulizumab. Currently, the drug is in Phase II stage of its development for the treatment of Mycosis Fungoides.

Further product details are provided in the report……..

Mycosis Fungoides: Therapeutic Assessment

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

Major Players in Mycosis Fungoides

There are approx. 4+ key companies which are developing the therapies for Mycosis Fungoides. The companies which have their Mycosis Fungoides drug candidates in the most advanced stage, i.e. Phase III include, Soligenix.

Phases

DelveInsight’s report covers around 6+ 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

Mycosis Fungoides 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.

Mycosis Fungoides: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Mycosis Fungoides 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 Mycosis Fungoides drugs.

Mycosis Fungoides Report Insights

• Mycosis Fungoides Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Mycosis Fungoides 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 Mycosis Fungoides drugs?
• How many Mycosis Fungoides drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Mycosis Fungoides?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Mycosis Fungoides 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 Mycosis Fungoides and their status?
• What are the key designations that have been granted to the emerging drugs?