This report has been UPDATED with the latest news from Ahammune Biosciences on September 25, 2024.

Our exclusive analysis provides an in-depth understanding of the highly competitive landscape for vitiligo therapies, highlighting key biotech, pharma and AI companies involved in drug development and treatment, as well as clinical trial statuses, pharmacological actions, agreements and collaborations, and stock price trajectories.

While a report of this caliber would typically cost $2,000 elsewhere, as a friend of the VR Foundation, you can access it for free.

Disease

Vitiligo is a life-long, non-contagious, immune-mediated, systemic disease affecting the largest body organ and other vital systems. The actual cause for vitiligo is typically unknown; it is believed to be due to genetic susceptibility that is activated by emotional distress, environmental factors, certain chemicals or toxins, altered cellular environment, physical skin damage, impaired digestion or hormonal changes. In more than 50% of cases, the disease onset is prior to the age of 20 years, and is progressive especially in the first 10–20 years. Vitiligo signs and activity vary considerably from person to person.

Vitiligo prevalence is between 0.76% and 1.11% of the U.S. population, including around 40% of those with the condition being undiagnosed, according to the study Prevalence of Vitiligo Among Adults in the United States. Worldwide prevalence estimates of vitiligo vary widely, ranging from 0.004% to 2.28% and even higher in certain regions; however, most are outdated, did not include those with undiagnosed vitiligo, sampled from specific groups or extrapolated from other studies.

The total number of people suffering from vitiligo is estimated at around 65-95 million people worldwide, however, treatment seeking population numbers would be quite different in different countries due to prevalent skin color and social stigma attached.  More about vitiligo

Therapies

There is currently no cure for vitiligo, nor a universally accepted method to halt its progression. While visible symptoms can be temporarily reversed with various treatments, combinations of therapies are generally more effective than monotherapy. However, predicting the most effective treatment for individual patients remains challenging, often involving a trial-and-error approach.

First-line therapies for vitiligo typically involve the off-label use of corticosteroids and calcineurin inhibitors, either alone or in combination, to suppress the cellular immune response, particularly effective in the disease's early stages. Since 2022, Opzelura® (Ruxolitinib 1.5% cream) by Incyte has been the only approved treatment for nonsegmental vitiligo in the U.S. and EU, and it is gaining broader acceptance. In the U.S., Incyte’s Patient Affordability program makes Opzelura accessible to the majority of commercially insured patients, for as low as $5 per prescription. It is now covered for over 85% of such individuals in the U.S. and over 70% in the EU, although coverage and prices vary across the Union.

The most common second-line therapy combines corticosteroids, calcineurin inhibitors, and narrow-band UVB phototherapy to stimulate melanogenesis. Adhering to this treatment protocol for 8-12 months can lead to near-complete repigmentation of facial lesions and the upper trunk in about 75% of patients. Unfortunately, white lesions often reappear after treatment is stopped, with relapse occurring in nearly half of all patients within 4.5 years.

Combination therapies dominate the vitiligo treatment market, which is projected to reach $2 billion by 2026. While this may seem significant, it pales in comparison to the $19 billion market for aesthetic devices or the $38 billion psoriasis market. 

The abundance of moderately effective combination therapies has historically restrained new drug development for vitiligo. However, this is expected to change rapidly in the next three to seven years, as both large and small biopharma companies focus on developing targeted treatments. Repurposing existing drugs offers the fastest path to new vitiligo therapies, likely requiring $150-$200 million. In contrast, developing a new drug demands nearly $1 billion and takes 12-15 years.

Companies

The treatment market for vitiligo is expected to reach $822.75 million by 2028. Incyte, with its topical ruxolitinib (Opzelura) as a key contributor, while Pfizer is advancing its oral ritlecitinib (Litfulo), currently in Phase 3 clinical trials for vitiligo. Incyte has further strengthened its position through the acquisition of Villaris Therapeutics, adding the promising asset auremolimab (VM6) to its pipeline.

Other companies with off-label vitiligo products include Allergan (Prostoglandin), Astellas Pharma (Protopic), Accord Healthcare (Tacrolimus), Bausch Health (Methoxsalen), Belcher Pharmaceuticals (Tacrolimus), Bristol-Myers Squibb (Abatacept), Celgene (Apremilast), Glenmark (Tacrolimus), Dr. Reddy's Laboratories (Melgain), Mylan (Pimecrolimus), Panacea Biotec (Pangraf / Tacrolimus), Pierre Fabre (Fluorouracil), Philadelphia Pharmaceuticals (Vitilase / pseudocatalase), Puneet Laboratories (Albaquin), Reistone Biopharma (Ivarmacitinib), Salix Pharmaceuticals (Azathioprine), Sesderma (Vitises), Strides (Methoxsalen), and Teva Pharmaceuticals (Betamethasone).

The pipeline for vitiligo treatments is expanding, with emerging therapies such as upadacitinib (AbbVie), povorcitinib (Incyte), and AMG-714 (Amgen) showing promise. These developments are driven by increasing disease prevalence, growing awareness, and substantial R&D investments in the field.

Regionally, North America dominates the vitiligo treatment market, benefiting from advanced healthcare infrastructure and higher treatment adoption rates. However, significant growth is expected in other regions as access to treatments improves.

While there is optimism surrounding vitiligo therapies from established pharmaceutical companies, concerns persist regarding side effects and the durability of therapeutic effects. Ongoing research aims to address these issues, improving both efficacy and safety profiles. Simultaneously, smaller startups like Skinopathy are exploring innovative approaches, potentially offering new hope for vitiligo patients and attractive opportunities for life sciences investors.

 

New Developments

Drug candidates that have entered clinical trials or are pending approval by the U.S. Food and Drug Administration (FDA) are often described as being "in the pipeline." A biotech company's pipeline of emerging products is a critical factor in assessing its market potential. This brief analysis of the vitiligo drug pipeline offers insights into the trends shaping the vitiligo market. However, it's important to note that clinical plans don't always come to fruition, and biotech companies can face setbacks due to FDA regulatory decisions.

🇺🇸  AbbVie recently confirmed it's commitment to research in skin diseases, including vitiligo, but no specific details were provided. Their website offers a hint that a small molecule inhibitor of RoRγT being investigated for the treatment of immune-mediated diseases. The list of 2024 IIS Strategic Priorities includes vitiligo without further details. 

❌ Ache Laboratorios Farmaceuticos reportedly set aside $100M for vitiligo candidate drug ACH24, expected to complete trials in 2023. The Brazilian regulatory agency - ANVISA - has requested the cancellation of the Phase 3 study for conducting a Phase 1 study first. No further information is available on the company's website.

❓Aclaris Therapeutics’ lead drug candidate ATI-50002 Topical Solution 0.46% for vitiligo is a JAK1/JAK3 inhibitor; Phase II clinical trial completed in 2020 with no further development. In January 2024 company announced top-line results from its Phase 2b study of ATI-1777, an investigational topical “soft” JAK 1/3 inhibitor, in patients with mild to severe atopic dermatitis, with an eye for vitiligo down the road. 

🇮🇳 Ahammune Biosciences, a startup with an eight-member team, has developed its first pipeline product aimed at treating the early stages of vitiligo. Their candidate, AB1001, targets T cell activation and potentially other pathways that trigger autoimmunity, helping to prevent the spread of the disease. In January 2023, the company successfully completed Phase I clinical trials, and with a fresh $5M investment in September 2024, they’re now moving into Phase II. Founded in 2016, Ahammune previously secured funding in a pre-Series A round from Ideaspring Capital and Indian Angel Network, though the amount was undisclosed. 

🇪🇸 Almirall, a global biopharmaceutical company, is actively exploring academic partnerships to investigate pathological mechanisms of atopic dermatitis, hidradenitis suppurativa, and vitiligo. In 2022, Almirall announced a licensing agreement and research collaboration with Inserm Transfert, the private subsidiary of the French National Institute of Health and Medical Research (Inserm), led by Prof. Thierry Passeron.

🇺🇸 Alys Pharmaceuticals emerged as a new player in dermatology, pooling the strengths of six biotech startups with a $100M boost from Medicxi. Alys aims to expand its focus on inflammatory and autoimmune diseases, dermatology care for cancer patients, and rare skin conditions. The company's goal is to deliver seven to ten clinical Proof-of-Concept readouts in the next three years, potentially advancing at least one program to further studies. 

🇺🇸 Amgen is developing AMG 714, an experimental drug designed to block IL-15, a chemical signal involved in the activity of tissue resident memory (Trm) immune cells that are believed to attack pigment-producing melanocytes in vitiligo. By inhibiting IL-15 signaling, AMG 714 could potentially halt the immune system's attack on melanocytes, allowing for repigmentation of the skin. The drug is currently in Phase 2 trials, with completion expected by May 2025.

❌ AnaptysBio with its Rosnilimab (formerly ANB030, Anti-PD-1 Agonist) program has moved into P2b initiation phase for rheumatoid arthritis in Q3 2023; interest in vitiligo is no longer acknowledged on the company's website. 

❌ Applied Biology has developed Photocil, a sunscreen with a "therapeutic window" at around 308 nm that mimics narrowband phototherapy under the sun. Originally, Photocil was marketed as "Phototherapy in a bottle", an over-the-counter drug for the treatment of psoriasis and vitiligo. Jupiter Wellness (rebranded as Safety Shot in 2023, see below) has acquired global rights for the product in July 2022. Branded as PhotoFirst, it has been approved by the Central Drugs Standard Control Organisation (CDSCO) in India, in November 2022. 

🇺🇸 Arcutis Biotherapeutics in-licensed SHR0302, the active ingredient in ARQ-252, a potent JAK1 inhibitor, from Jiangsu Hengrui Medicine Co. Arcutis believes the compound offers significant treatment potential without the hematopoietic side effects linked to JAK2 inhibition. The company raised $166M to develop three dermatological drug candidates. However, in June 2021, Arcutis terminated the Phase IIa study of ARQ-252. Despite this, the company still views it as a "promising strategy" for treating chronic hand eczema and vitiligo, with the compound now at the pre-clinical stage.

❓Arrien Pharmaceuticals is developing ARN-4079, an oral JAK3 inhibitor targeting the unique Cys909 residue. The privately funded company, with $2M in backing, plans to file for an IND to treat vitiligo, rheumatoid arthritis, atopic dermatitis, and other skin conditions since it has first appeared on our radar screen. Currently, Arrien is seeking partnerships for IND-enabling studies and Phase 1 trials. However, it's unclear if their collaboration with Boston Pharmaceuticals covers vitiligo, which could pose a potential conflict of interest.

🇺🇸 Avita Medical’s technology creates an autologous suspension from a piece of the patient's own normal skin in under 30 minutes, to spray pigment-producing cells onto vitiligo lesion. The FDA-approved technology works best on stable vitiligo, which is defined as no change in the shape or number of lesions for 6-12 months.

❓ Over three years ago, AXIM Biotechnologies filed patent application for a method to treat vitiligo with a topical composition containing cannabidiol and cannabigerol, but this drug candidate — AX-1602 — didn’t appear in the company’s pipeline. Results of only one proof-of-concept study conducted with one participant perhaps weren’t convincing enough, and company is developing cannabiod-based products for other indications.

❓ Biolojic Design, an Israeli firm, uses AI and computational design to develop innovative antibody-based treatments for autoimmune conditions. Their AI platform creates antibodies that precisely target specific epitopes, either activating or inhibiting biological pathways, and can also produce multi-specific antibodies functioning as biological logic gates. In December 2023, Teva Pharmaceuticals and Biolojic Design announced an exclusive license agreement to develop a dual-specific antibody targeting Thymic stromal lymphopoietin (TSLP) and IL-13 for treating atopic dermatitis and asthma, with potential applications in vitiligo.

❓ Bioniz Therapeutics / Almirall has leveraged its proprietary multi-cytokine inhibitor platform technology to develop BNZ-1 for an immuno-dermatology franchise in vitiligo, cutaneous T-cell lymphoma and alopecia areata. Multi-cytokine inhibitor is selectively targeting three interleukins, IL-2, IL-9, and IL-15.  The lead product candidate has completed Phase 1 SAD and MAD clinical trials in healthy volunteers and is currently in Phase 1/2a clinical development.

❌ Boston Pharmaceuticals in-licensed topical compound BOS-475 (formerly GSK3183475) to treat vitiligo and psoriasis, which GSK put up for auction after the new CEO restructured the company’s R&D activities. It didn't show up on the company's pipeline. 

❌ Castle Creek Pharma does not explain its development plans for CCP-070, other than to say it is in the preclinical stage for a ‘rare dermatologic condition’ (arguably, EPP) and vitiligo. Castle Creek licensed these tri- and tetra-peptide melanotropic analog series from Prof. Abdel-Malek at the University of Cincinnati a few years ago. Promising peptide structures are small enough to achieve dermal penetration after topical application, but Castle Creek will have to do all the preclinical toxicology from scratch. Company privately raised $71.8M to date. 

🇦🇺 Clinuvel’s Scenesse, a synthetic analog of alpha-melanocyte-stimulating hormone (α-MSH), is currently in a Phase 3 trial to assess its efficacy and safety in combination with phototherapy for vitiligo treatment. As of September 2024, the study is recruiting patients across the U.S., focusing on those with Fitzpatrick skin types IV to VI due to their higher repigmentation potential. This trial uses a higher afamelanotide dosage (16 mg) compared to previous studies. Concerns remain about the potential for diffuse hyperpigmentation in lighter skin types, and the durability of repigmentation post-treatment is still uncertain. 

❌ Dermavant (see also Roviant Sciences) has been advancing a pipeline of treatment candidates for vitiligo, psoriasis and atopic dermatitis with Cerdulatinib, a dual inhibitor of the Janus kinase (JAK) and spleen tyrosine kinase (Syk) pathways. Lot's hopes were put on their topical JAK/Syk inhibitor (also named DMVT-504 or RVT-502, in-licensed from Portola Pharmaceuticals for topical indications) so company could turn its net loss of $250M to profit someday, but it was "un-prioritized" in July 2022. 

🇮🇳 DRDO (Defence Research Development Organisation) is an Indian government research organization. The Herbal Medicine Division of DRDO’s Defence Institute of Bio-energy Research (DIBER) at Pithoragarh has developed product Lukoskin, which is presently manufactured and marketed by Delhi-based AIMIL Pharma Ltd. The ointment has seven herbal ingredients to increase photosensitivity and promote melanogenesis. The treatment regimen is typical for Ayurvedic medicines, as well as it's efficacy. 

🇨🇦 Edesa Biotech, a Canadian clinical-stage biopharmaceutical company, is developing EB06, anti-CXCL10 monoclonal antibody for treating vitiligo. CXCL10 is highly expressed in vitiligo patients and is involved in both the initiation and maintenance of vitiligo lesions. EB06 targets autoreactive T cells that destroy pigment-producing cells in the epidermis. The company entered Phase 2 clinical trials on February 1, 2023.

❓ Eligo Bioscience received the first patent in a wide family covering genetic engineering of a key skin microbiome species, Cutibacterium acnes. It is designed to support therapeutic interventions in multiple serious skin disorders, including vitiligo, yet the company is currently focused on treatment of moderate-to-severe acne vulgaris. Eligo was founded by scientists from The Rockefeller University and from MIT, with funding provided by big names in venture and pharma industries. 

🇺🇸 Forte Biosciences addresses various autoimmune diseases, such as graft-versus-host disease, and vitiligo and alopecia areata. It's FB-102 is currently in Phase 1 for vitiligo, and meangful details are not yet available. 

🇨🇭 Idorsia Pharmaceuticals' drug discovery engine focuses on novel molecular target families, including G-protein coupled receptors (GPCRs) and specific enzymes. While this broad approach may yield candidates for vitiligo treatment, it seems to be a relatively minor focus compared to their more advanced pipeline candidates in other indications. One such candidate, coded ACT-777991, is a CXCR3 antagonist currently in preparation for Phase 2 trials for vitiligo.

🇺🇸 Incyte Corporation developed Opzelura, a 1.5% topical ruxolitinib treatment for vitiligo, targeting the overactive TH1 immune response responsible for depigmentation. In clinical trials, Opzelura achieved over 75% improvement in facial vitiligo in 30% of patients after 24 weeks, with a significantly higher proportion showing at least 50% improvement. As the first and only FDA and EMA-approved prescription treatment for the most common form, nonsegmental vitiligo, Opzelura generated $337.9 million in 2023, with projected sales of $1.4 billion by 2029. In 2022, Incyte acquired Villaris Therapeutics and the rights to auremolimab (VM6), an anti-IL-15Rβ monoclonal antibody, which has shown efficacy in preclinical vitiligo models.

🇮🇳 Issar Pharma Pvt developed the original decapeptide Melgain for vitiligo treatment. In 2016, Zydus, a top-5 Indian pharma company, acquired the rights to the product and now markets it under its brand name. Zydus also has the option to launch Melgain in other global markets where it is not yet available. In India, Melgain is marketed by Liva Healthcare.

🇦🇺 Incannex Healthcare is focused on developing medicinal cannabinoid and psychedelic pharmaceutical products and therapies. Their proprietary topical cannabinoid formulation, ReneCann, targets dermatological conditions caused by immune system disorders, including vitiligo, psoriasis, and atopic dermatitis (eczema). It's candidate, APIRx-1601, has completed a proof-of-concept study for vitiligo, though no further details have been disclosed.

🇺🇸 JN Biosciences’ HuABC2 drug candidate is a humanized anti-CD122 IgG antibody that has a unique function to suppress CD122/CD132-bearing NK and memory T cells. Therapeutic activity of HuABC2 was demonstrated in mouse disease models for vitiligo, type I diabetes, alopecia areata, multiple sclerosis, and celiac disease. The company is seeking an out-licensing deal for HuABC2.  

🇰🇼 Kuwait University introduced a new vitiligo treatment by Dr. Mohammad Alansary in early 2021. The VT Treatment package includes plant-extracted materials like tyrosinase co-factors, heme-oxygenase inducers, peroxynitrite scavengers, and anti-inflammatory ingredients. It’s suited for patients with Fitzpatrick skin types III and above, with UVA or UVB phototherapy recommended for better results. A production deal with Dutch company Rebel-Nature is in place, though mass production may be challenging due to the nature-based ingredients.

🇺🇸 Merck enhanced its vitiligo candidate portfolio in 2021 by acquiring Pandion Therapeutics, whose lead candidate is an engineered IL-2 mutein fused to a protein backbone, designed to selectively activate and expand regulatory T cells (Tregs). This acquisition also included PD-1 agonists under development for various autoimmune conditions. Merck's MK-6194, currently in a global Phase 2 trial codenamed REGINA, is being tested for non-segmental vitiligo and systemic lupus erythematosus (SLE), with the trial expected to continue until the end of 2025.

🇩🇰 LEO Pharma interest in vitiligo goes back many years, without formal acknowledgement. Perhaps, repurposing a well-known topical immunosuppresant Protopic (aka FK-506, fujimycin, Tacrolimus, Prograf) for vitiligo would be the fastest entry for LEO Pharma into the burgeoning market. Recent studies suggest that twice-daily application of tacrolimus 0.1% ointment for 24 weeks reduces facial vitiligo lesions in 65% of patients, with 40% relapse rate at 48 weeks.

🇬🇧 Life Science Investments, a UK-based company with R&D facilities in Guayaquil, Ecuador, completed pre-clinical trials for VitiLSiGel in early 2020, and launched product next year. This cosmeceutical formulation, based on Coleus forskohlii root and Cassia alata leaf extracts, has melanogenesis-inducing, anti-inflammatory, and immunomodulatory properties. While case reports indicate effectiveness in treating acrofacial vitiligo, the ideal patient candidate has yet to be determined.

🇺🇸 Nektar Therapeutics presented the first preclinical data on NKTR-0165, a new drug designed to specifically activate TNFR2, a protein that controls inflammation by enhancing regulatory T cells (Tregs). This approach could pave the way for new treatments for autoimmune diseases like ulcerative colitis and vitiligo. Preclinical studies show that NKTR-0165 effectively reduces inflammation by boosting Treg activity, positioning it as a unique and promising therapy in the TNFR2-targeted treatment field.

🇺🇸 OM1, a Boston-based company, uses AI and large-scale data analytics to advance dermatological R&D, focusing on conditions like vitiligo. Along with Skinopathy (see below), it reflects a growing trend in healthcare towards improving patient outcomes through non-pharmaceutical approaches. 

❓ Ornovi is developing a selective JAK3/ITK dual inhibitor to treat alopecia areata, vitiligo, and other inflammatory and autoimmune diseases involving JAK3. Although the inhibitor is officially in Phase 1, the company's pipeline hasn't been updated in over a year, leaving its current status unclear.

❓Palatin Technologies filed patent application for melanocortin receptor-1 peptides (MC-1) back in 2013. Proposed indications included vitiligo and erythropoietic protoporphyria, but apparently it hasn’t yet entered the development phase.

❌ Pandion Therapeutics' lead candidate, PT101, is an engineered IL-2 mutein fused to a protein backbone, designed to selectively activate and expand regulatory T cells (Tregs) for treating autoimmune diseases. PT101 completed a Phase 1a clinical trial. The modular design of Pandion’s pipeline allows for combining a specific tissue tether with an immune effector molecule within a bifunctional antibody. Pandion's potential was recognized by the market, leading to a successful $135 million IPO in 2020. The following year, pharmaceutical giant Merck (see above) acquired Pandion for $60 per share, valuing the company at approximately $1.85 billion.

🇫🇷 Pierre Fabre, a French pharmaceutical and dermocosmetics group, is on our watch list for its (yet) unacknowledged interest in vitiligo. In 2023, the company presented the first international epidemiological study on the prevalence and psychosocial impact of visible chronic dermatoses, including eczema, hand eczema, acne, psoriasis, ichthyosis, vitiligo, and rosacea. Notably, one of the company's products, 5% 5-fluorouracil, has been actively used off-label for vitiligo treatment, particularly in India. 

🇺🇸 Pfizer's new drug, Ritlecitinib, marketed under the brand name LITFULO™, is an anti-inflammatory and immunosuppressive medication recently approved for the treatment of severe alopecia areata in the USA and Japan. It is the first oral JAK3/TEC inhibitor to successfully complete a Phase 2b clinical trial for vitiligo, demonstrating the ability to stabilize active lesions and repigment stable ones, though longer treatment is needed to fully assess its efficacy in active lesions. A Phase 3 trial is currently underway, with an estimated completion date in June 2025.

❌ Rheos Medicines focused on developing therapeutics that modulate metabolic pathways in CD4 and CD8 T cells. Its ‘Program #1’ targeted T-cell effector responses for lupus and vitiligo and was in the ‘drug discovery’ phase. In early 2018, the company secured $60M from Third Rock Ventures to build a drug discovery platform. By late 2019, Rheos struck a nearly $800 million deal with Roche to develop new drugs for autoimmune and inflammatory diseases, granting Roche exclusive rights to explore immunometabolism using Rheos’s platform. Unfortunately, Rheos shut down in 2023.

❓ Rhythm Pharmaceuticals reported an 'undesired side effect' of skin darkening during clinical trials of Setmelanotide, which activates the melanocortin 4 receptor (MC4R) signaling pathway and is currently in Phase 3 for rare monogenic obesity. While the tanning effect isn’t as pronounced as with Clinuvel’s Scenesse, the possibility of addressing both uncontrolled hunger and vitiligo with one treatment is intriguing. 

❌ Roviant is a biopharmaceutical technology company that develops product candidates for the treatment of various therapeutics, from solid tumors to vitiligo. In mid-2022 the company has discontinued development of several assets following a 'pipeline reprioritization,' including Cerdulatinib, a topical JAK/Syk inhibitor. It's subsidiary Dermavant is in the process of closing out the development of DMVT-502 (504) for vitiligo and atopic dermatitis, in-licensed earlier from Portola Pharmaceuticals for topical indications.

🇺🇸 Safety Shot (formerly Jupiter Welness) is a wellness and functional beverage company, mostly known for its Safety Shot Beverage, an over-the-counter drink that lowers blood alcohol content. It has bought rights for Photocil therapeutic sunscreen from Applied Biology (see above) to address psoriasis and vitiligo.

🇪🇸 Sesderma has a longstanding interest in vitiligo, supported by its VITISES line of cosmeceutical products aimed at hypopigmented skin. These products utilize proprietary nanotechnology to deliver active ingredients encapsulated in liposomes, specifically formulated for the daily care of skin affected by vitiligo. However, for reasons that remain unclear, VITISES products are not actively marketed in the EU or USA.

🇨🇦 Skinopathy is drawing significant attention from leading pharmaceutical companies with its next-generation, AI-powered skin diagnostic and management tool. The company's innovative approach earned it a spot among the Top Early Companies, as recognized by the Canadian Innovation Exchange (CIX). Skinopathy's AI for managing vitiligo was prominently featured at the World Vitiligo Day 2024 conference in Cali, Colombia.

🇺🇸 Strata Skin Sciences is one of the leading producers of in-office phototherapy devices. Its flagship product, the XTRAC® excimer laser system, uses targeted UVB light to treat skin conditions like vitiligo and psoriasis. Recently, Strata expanded its portfolio by acquiring the TheraClear®X Acne Therapy System, a non-invasive photopneumatic device designed for mild-to-moderate acne treatment, allowing the company to enter a new market.

🇺🇸 Temprian Therapeutics is developing TT-01, a DNA-based treatment for vitiligo using a modified heat shock protein 70i (HSP70i) created by Professor Caroline Le Poole. Supported by $4 million grant from the NIH, TT-01 involves four needleless DNA plasmid injections aimed at inducing long-lasting, whole-body repigmentation, including distant lesions—a potential leap beyond current localized treatments.

🇺🇸 TeVido BioDevices has launched TruPigment, enabling physicians to perform skin cell transplants for localized vitiligo without costly equipment or extensive training. The procedure uses a sample of the patient’s healthy skin cells for office-based transplantation, making this treatment more accessible for patients with stable vitiligo, though availability in the U.S. is still limited. TeVido has raised $1.421 million in private funding to date.

🇮🇳  Uniza Healthcare, a pharmaceutical venture of Pashupati Group, has launched Vitellus, a unique combination of palmitoyl tetrapeptide with pro-melanogenic and antioxidant supplements, in partnership with Canadian company Lucas Meyer Cosmetics and Indian company Amvigor Organics. While peptide-based lotions for vitiligo have been available in India since 2004, their efficacy has often fallen short of marketing claims.

❌ Vallaurix, a subsidiary of Clinuvel Pharmaceuticals in Singapore, announced in 2020 the development of VLRX001, a smaller version of the melanocortin analogue afamelanotide, designed to improve and prolong cellular activity. This new topical drug candidate is intended for ‘adjuvant maintenance therapy’ in vitiligo patients, likely targeting those with darker skin types (Fitzpatrick IV-VI). However, the lack of further details or online updates suggests that this project may have been suspended.

❌ Vilacto Bio with its patented drug delivery system Lactoactive can contribute significantly to emerging therapies for treating a number of diseases, including vitiligo. However, the company stock is barely trading with a market cap of $0.320M and negative outlook. 

❌ Villaris Therapeutics, founded by Dr. John Harris and backed by $18M from Medicxi, is developing auremolimab (VM6), a humanized anti-IL-15Rβ monoclonal antibody targeting resident memory T-cells. Expected to enter clinical development in 2024, auremolimab follows a similar approach to Amgen's AMG 714, which was later licensed to Provention Bio for celiac disease. In October 2022, Incyte acquired Villaris Therapeutics for $70 million upfront, with potential milestones reaching up to $1.36 billion.

🇺🇸 Vyne Therapeutics has developed VYN201, a BET (bromodomain and extraterminal) inhibitor for treating vitiligo. Unlike JAK inhibitors, VYN201 targets gene transcription related to inflammation and immune responses, preventing CD T-cell expansion, reducing MMP-9, and stabilizing melanocytes. In a small Phase 1b trial, VYN201 showed a 39% improvement in facial pigmentation after 16 weeks, with a good safety profile and rapid action. VYNE is now preparing for a larger Phase 2b study. VYN201 could represent a significant advance in vitiligo treatment and the first clinical success of a BET inhibitor in autoimmune diseases.

❓ Xinjiang Biomedicine Innovation and Research Center reported a "significant progress" in developing traditional Uygur medicines for vitiligo, in collaboration with colleagues from Uzbekistan, yet the complete picture isn't clear. 

🇺🇸 Zerigo Health (formerly Clarify Medical) has developed a portable NB-UVB device that connects to an app on the patient’s smartphone, allowing for precise management of light therapy dosage, frequency, and duration. While the treatment regimen is prescribed by the patient’s physician, it is monitored and controlled through the app. The 'connected' Clarify System has received FDA clearance for localized phototherapy.

 

Conclusion

The landscape of vitiligo therapies has undergone a remarkable transformation since I began this report. What started as a single company has blossomed into a vibrant ecosystem of over 50 players in just a decade. This journey has been marked by both triumphs and challenges—some startups navigated the treacherous "Death Valley" of vitiligo R&D on their own, while others found success through substantial acquisitions. This rapid evolution underscores both the immense potential and the complex hurdles in this field.

I've poured considerable time and energy into crafting this comprehensive report, which I'm delighted to offer free of charge to our loyal VRF subscribers. But our exploration doesn't end here! I'm already immersing myself in research for my next report, which will delve into the fascinating intersection of artificial intelligence (AI) and vitiligo treatment advancements. Stay tuned for more cutting-edge insights as we continue to unravel the future of vitiligo therapies together. 

Yan Valle, CEO VR Foundation

All prices are in US dollars and all information is correct at the time of writing. This post by is general in nature, and does not constitute a financial advice. If you spot an error that warrants correction, please contact the author at yan@vrfoundation.org 

 

Further Reading

"Emerging drugs for the treatment of vitiligo" has been published in the journal Expert Opinion on Emerging Drugs. This co-authored  study comprehensively summarizes the current concepts in the pathogenesis of vitiligo with special focus on the cytokine and signaling pathways, followed by antioxidant mechanisms and repigmenting mechanisms.

Drug Pipelines

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