UPDATED: January 10, 2023
Our exclusive analysis will help you understand a higly competitive environment for vitiligo therapies, the key biotech and pharma companies involved in vitiligo drug development, clinical trial status, pharmacological action, agreements and collaborations, and stock price trajectory. A report like this would cost $2,000 minimum elsewhere, but as a friend of VR Foundation, you can read this free.
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estimates of vitiligo vary widely, ranging from 0.004% to 2.28% and even higher in certain regions; however, most are outdated, did not include those with undiagnosed vitiligo, sampled from specific groups or extrapolated from other studies.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
There’s currently neither a cure for vitiligo, nor a universally accepted method for limiting the spread of the disease. Visible symptoms are temporarily reversible with a range of treatments, and their combination works far better than a monotherapy. However, it is often not possible to predict what will work best for which patients. The choice of therapy is often characterized by trial and error.
Vitiligo therapies today are mainly represented by the off-label use of corticosteroids and calcineurin inhibitors, both as monotherapy and combination therapies. These therapies act by diminishing the cellular immune response. Corticosteroids and calcineurin inhibitors constitute the first line of treatment and are most effective in an early onset of the disease. Ruxolitinib cream (see Incyte here below) is the only FDA-approved prescription treatment for vitiligo repigmentation in USA, and soon expected to be approved in the EU.
The most common second-line therapy is a combination of corticosteroids, calcineurin inhibitors, and narrow-band UVB phototherapy to stimulate melanogenesis. By sticking to the proper treatment protocol over 8-12 months, approximately 75% of patients can achieve a near-complete repigmentation of facial lesions and upper trunk. Unfortunately, white lesions frequently reappear when treatment is discontinued, with relapse occurring in nearly half of all patients within 4.5 years of stopping treatment.
Combination therapies contribute the most toward the vitiligo treatment market size, which is expected to reach $2B by 2026 (that may seem large, but compare it to aesthetic devices with its $19B or psoriasis with its $38B share of the market and you get some perspective).
A plethora of moderately effective combination therapies have always been a restraint to new vitiligo drug development. However, it’s expected that the dynamics of the vitiligo market will change rapidly in the next three to seven years, as both big and small biopharma companies have started to focus on the development of targeted treatments for vitiligo.
Repurposing of the existing molecules or drugs is the fastest way to introduce new therapies for vitiligo – to the tune of probably $150-$200 million. By contrast, new drug development requires close to $1 billion investment and takes 12-15 years.
The top key players in the vitiligo market today are Incyte (with topical ruxolitinib branded Opzelura) and Pfizer (with PF-06651600 candidate) as JAK3 inhibitors.
Other companies with mainly 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), Salix Pharmaceuticals (Azathioprine), Sesderma (Vitises) and Strides (Methoxsalen).
For all the optimism surrounding vitiligo therapies from these big pharma companies, my major concern is about their side-effects and short-lived therapeutic effect. Smaller biotech startups may hold more hope for vitiligo patients and are most attractive for investors in the life sciences industry.
Drug candidates that have entered into clinical trials or pending approval by the U.S. Food and Drug Administration (FDA) are often said to be "in the pipeline." A biotech company's pipeline of up-and-coming products is a critical factor in evaluating its market potential. This quick analysis of vitiligo drug pipeline may help you understand the trends shaping and driving the vitiligo market. Keep in mind that clinical plans don't always come to fruition and sometimes biotech companies can suffer at the hands of regulatory decisions from the FDA.
At the EADV congress this year, AbbVie confirmed it's commitment to research in skin diseases, including vitiligo, but no specific details were provided. Their website provides a hint that a small molecule inhibitor of RoRγT being investigated for the treatment of immune-mediated diseases.
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. Specific details are not yet available.
Aclaris Therapeutics’ lead drug candidates for vitiligo are ATI-502 and ATI-1777, respectively a JAK1/JAK3 inhibitor — currently in Phase II clinical trial — and IND-enabling studies. The company appears to be burning cash quickly, with uncertain prospects. The major concern here was an ongoing investigation of whether the Company issued misleading statements about risk and efficacy of one of its products and class action lawsuit; the latest development aren't clear.
Ahammune Biosciences Pvt. Ltd. is a startup company based in Pune, India. Ahammune’s first pipeline product, AB1001, is designed to treat early stages of vitiligo. The product targets the activation step of T cells, preventing further killing and spread. IND-enabling studies were planned for 2020 but we heard no official announcement yet.
AnaptysBio with its ANB030 (Anti-PD-1 Agonist) program is moving into a healthy volunteer Phase 1 trial, with top-line data anticipated in mid-2021. If all goes well, Phase 2 clinical trials in alopecia areata and vitiligo are scheduled for Q4 2021.
📌 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, a developer of endocannabinoid products for skincare - including hair loss, eczema, burns, and sexual wellness - 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 and highly selective inhibitor of janus kinase type 1 (JAK1), from Chinese company Jiangsu Hengrui Medicine Co. Arcutis believes this compound has a promising treatment potential without hematopoietic adverse effects typically associated with JAK2 inhibition. The privately held company raised $166M to develop three dermatological drug candidates. In June 2021, it terminated the Phase IIa study evaluating ARQ-252. Per the company, it still remains a "promising strategy for the treatment of both chronic hand eczema and vitiligo."
Arrien Pharmaceuticals develops an orally available JAK3 inhibitor ARN-4079, which targets unique Cys909 residue at the gatekeeper position. Company is privately funded to the tune of $2M. The company plans to file for IND to treat vitiligo, rheumatoid arthritis, atopic dermatitis and other skin diseases. It is currently seeking partnerships that will help it fulfill IND-enabling studies and Phase I clinical trials. It is unclear whether Arrien’s collaboration with Boston Pharmaceuticals (see below) also covers vitiligo, which would create a potential conflict of interests.
📌 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 technology works best on stable vitiligo. The company is pushing into the new markets like China, home to 12 million vitiligo patients. In December 2022, company announced submission of a Premarket Approval application (PMA) to the U.S. FDA. for its RECELL® System. This PMA application follows the original PMA approval in September 2018. It includes the recently released results of the trial, which achieved its primary effectiveness endpoint of super-superiority.
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. Stock price bounced between wildly over the last year while company was focused on its COVID-19 rapid diagnostic test.
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 Phase1/2a clinical development in CTCL. These clinical data presented in November 2020 are the first to demonstrate therapeutic efficacy of BNZ-1. The closing of the option agreement by Almirall to buy Bioniz for $62M, plus additional milestone payments and royalties, will result in the generation of a Bioniz NewCo sometime in 2020-21.
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. This Phase I-ready compound is a small molecule inhibitor of Bromodomain and Extra-Terminal. It reduces the expression of pro-inflammatory mediators, such as IL-17 and Th1-associated chemokines.
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. While a topical drug is easier to develop, it still does not guarantee the systemic effect required to eliminate vitiligo from the body, like TT-01 (see below). Company privately raised $71.8M to date.
Clinuvel’s Scenesse is a first-in-class drug targeting erythropoietic protoporphyria (EPP), with an eye for vitiligo. In October 2019, FDA approved it for EPP. If all goes well with its three drugs – for EPP, variegate porphyria and vitiligo – experts say the company’s market cap may double. Vallaurix, a subsidiary of ClinuveI Pharmaceuticals in Singapore, develops a smaller version of afamelanotide under code name VLRX001 for vitiligo, see here below.
Dermavant / Roviant Sciences is 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. Hopefully, their topical JAK/Syk inhibitor (also named DMVT-504 or RVT-502, in-licensed from Portola Pharmaceuticals for topical indications) will move smoothly from Phase II study forward, and the company will turn its net loss of $250M to profit someday. The big troublesome issue on this name is the agreement with its investor NovaQuest.
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.
Edesa Biotech from Canada, a clinical-stage biopharmaceutical company, focused on novel immune targets implicated in vitiligo pathogenesis. The company has started a pre-clinical R&D with the National Research Council of Canada in late 2020. The collaborative project is designed to develop novel immunotherapies for vitiligo as well as other indications. At the turn of 2021, the company's market cap is $47m. Edesa Biotech collaborates with Yissum Research Development Company on the development of products for topical dermal and anorectal applications.
📌 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.
📌 Opzelura from Incyte Corporation aims at vitiligo with 1,5% topical ruxolitinib by suppressing the overactive TH1 arm of the body's immune system, which is responsible for the depigmentation. In the clinical trials it demonstrated an over 75% improvent in 30% patients' facial vitiligo after 24 weeks of treatment; a significantly greater proportion of patients achieved at least 50% improvement in total body Vitiligo Area Scoring Index. The U.S. FDA has approved it for sale in July, 2022, thereby making it the first and only FDA-approved prescription treatment for vitiligo repigmentation. In October 2022, Incyte has acquired Villaris Therapeutics (see here below) and rights to its lead asset, auremolimab (VM6), an anti-IL-15Rβ monoclonal antibody (mAb). Auremolimab has demonstrated efficacy as a treatment for vitiligo in preclinical models. IND-enabling studies are currently underway, and clinical development is expected to begin in 2023.
Issar Pharma Pvt is the developer of the original decapeptide Melgain for vitiligo treatment. A top-5 Indian pharma company Zydus has acquired rights to the product back in 2016 and will market the same under its brand name. Zydus has an option to launch this product in other global markets where it is not available. In India, Melgain is marketed by Liva Healthcare.
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. Another drug that blocks the same CD122 receptor has been already tested, though not for vitiligo (see below.) Privately held company, funding rounds unknown.
In early January 2021, Kuwait University has announced an effective new treatment against vitiligo developed by Dr. Mohammad Alansary. The two-component package "VT Treatment" includes a mixture of plant-extracted materials, like tyrosinase co-factors, Heme-oxygenase inducers, peroxynitrite scavengers and anti-inflammatory ingredients. Treatment is geared more towards patients with Fitzpatrick skin type III and above, as often the case with vitiligo therapies. The treatment produced in different types and concentrations to "tailor" to patients' responses. An additional UVA or UVB phototherapy is recommended for enhanced results. Production deal is inked with a Dutch cosmetic company Rebel-Nature; the mass-production supply side may be a challenge due to the nature-based ingreidients.
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 is a UK-based company with R&D facilities in Guayaquil, Ecuador. The company completed pre-clinical trials for VitiLSiGel in early 2020. This cosmeceutical formulation is based on Coleus forskohlii root and Cassia alata leaves extract, with melanogenesis-inducing, anti-inflammatory and immunomodulatory properties. The product was launched in June through a global network of distributors, with an estimated price tag of $60-70 for a 40g tube. Case reports show effectviness in acrofacial vitiligo but the ideal patient candidate isn't clear yet.
📌 Ornovi is a preclinical stage therapeutics company developing treatments for inflammatory and autoimmune diseases. Its key asset is a selective JAK3/ITK dual inhibitor for the treatment of alopecia areata, vitiligo, and other inflammatory and autoimmune diseases where JAK3 plays a role.
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 has entered public market after successful IPO in late 2020. The company raised $80 million in April of 2020, and brought in $135 million through the IPO in July. The potential of Pandion’s modular pipeline for autoimmune diseases allows for the combination of a specific tissue tether with an immune effector molecule within the same bifunctional antibody. Pandion recently reported that two of its tissue tethers, skin and gut, in combination with various effectors demonstrated promising results in animal models of vitiligo and graft vs. host disease, respectively.
Pierre Fabre, a French pharmaceutical and dermocosmetics group, is on our watch list for it's (yet) offcially unacknowledged interest in vitiligo.
A pharmaceutical giant Pfizer has been contending with a fierce patent cliff over the last few years, and also had a "brief pause” in clinical trial recruitments due to the pandemic. Yet, recent Pfizer’s entrant into the JAK inhibitor category with other indications was quite successful. The company has two unique immunokinase inhibitors in late-stage clinical trials for vitiligo: Ritlecitinib (PF-06651600) – an oral, JAK3/TEC family kinase inhibitor in Phase 2, and Brepocitinib (PF-06700841) – tyrosine kinase 2(TYK2)/JAK1 inhibitor in Phase 2 clinical trials, with a positive outook.
The initial focus of Rheos Medicines is on therapeutics that modulate metabolic pathways in immune cells — mainly CD4 and CD8 T cell subtypes. It's ‘Program #1’ is focused on suppressing T-cell effector responses for lupus and vitiligo, and according to the company’s website is currently in ‘drug discovery’ phase. In early 2018, the company received $60M from Third Rock Ventures for a comprehensive drug discovery platform based on findings from its academic founders.
Rhythm Pharmaceuticals reported an ‘undesired side-effect’ of skin darkening during the clinical trials of Setmelanotide, which activates the melanocortin 4 receptor (MC4R) signaling pathway and is currently in Phase III for rare monogenic forms of obesity. Tanning effect is not to the degree that Clinuvel’s Scenesse has, but killing uncontrolled hunger and vitiligo with one stone? Hmm…
Sesderma has a longstanding interest in vitiligo, backed with a number of cosmeceutical products in their VITISES line. It applies a proprietary nanotechnology in its formula to transport the active ingredients, encapsulated in liposomes. VITISES products are formulated for the daily care of hypopigmented skin that suffers from vitiligo. However, these products are not actively marketed in EU or USA for reasons still unclear.
Temprian Therapeutics works on advanced, DNA-based treatment for vitiligo under the code name TT-01. This therapy uses a modified HSP70i developed by Prof. Caroline Le Poole at Northwestern and Loyola Universities, largely through $4M funding from NIH. Four needleless DNA plasmid injections are supposed to cause a long-lasting repigmentation across the entire body, even at distant lesions. The company has made it to the finals of the Nature Spinoff Prize (July 2020) and is actively seeking partnerships to advance TT-01 development.
TeVido BioDevices launched TruPigment that allows physicians to provide skin cell transplants without making a costly investment in equipment and training. TeVido processes a sample of a patient’s healthy living cells, which is then used in a skin cell transplant procedure back at the doctor’s office. Skin cell transplants are a great treatment option for vitiligo patients with stable disease, but their number in the US is somewhat limited; expansion into SE Asia would be a logical next step. TruPigment was selected for prestigious SXSW startup competition just before the coronavirus lockdown, but then the company launched boutique testing services for COVID-19. Company privately raised $1.421M to date.
Uniza Healthcare, a pharmaceutical venture of Pashupati Group, has just launched Vitellus (as of October 4, 2021), a palmitoyl tetrapeptide combined with pro-melagenic and anti-oxidant supplements. The peptide-based lotions for vitiligo are marketed in India since at least 2004, but results don't quite match its marketing promise yet. The company targets markets like Africa, LATAM, South East Asia and CIS countries and plans to file over 180 dossiers for cosmetic products in different countries.
Vallaurix, a subsidiary of ClinuveI Pharmaceuticals in Singapore, develops VLRX001. This smaller version of afamelanotide — melanocortin analogue — can improve and prolong cellular activity. In short, afamelanotide increases melanin synthesis, thus decreasing the penetration of light into the skin. No other beneficial properties — e.g. anti-oxidant or anti-inflammatory — have been independently confirmed. This new topical drug candidate is intended for ‘adjuvant maintenance therapy’ in vitiligo patients — presumably those with darker skin types, Fitzpatrick IV-VI.
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 was founded by Dr. John Harris and backed by British VC firm Medicxi to the tune of $18M. Villaris is developing a novel humanized anti IL-15R antibody to target depletion of resident memory T-cells. Its lead asset, auremolimab (VM6), an anti-IL-15Rβ monoclonal antibody (mAb), is expected to enter clinical development in 2023. Amgen took a similar approach with different IL-15 targets in sight for AMG 714, but later out-licensed it to Provention Bio for non-responsive and refractory celiac disease. In October 2022, Villaris Therapeutics was acquired by Incyte (see here above) for an upfront payment of $70 million, up to $310 million as development and regulatory milestones, as well as up to an additional $1.05 billion in commercial milestones on net sales of the product.
📌 Vyne Therapeutics is running a Phase 1a/b clinical trial evaluating VYN201 for vitiligo. This drug candidate is a locally administered, small molecule, pan-bromodomain and extra-terminal domain (BET) inhibitor. VYN201 was found to upregulate the WNT signaling pathway which is an important mediator of both melanogenesis and melanocyte differentiation and is known to be dysregulated in patients with vitiligo. Library of BET inhibitors is licensed from Tay Therapeutics Ltd.
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 connected to an app on the patient’s own smartphone to manage the dose, frequency, and duration of targeted light therapy. The treatment regimen is prescribed by the patient’s physician but monitored and controlled by the app. The 'connected' Clarify System has been cleared by the FDA for localized phototherapeutic treatment.
The value of each candidate in the Drug Pipeline depends upon its progress through clinical trials. Our Trial Hub provides you with additional information about a drug candidate, trial purpose, recruitment status, age restrictions, locations, and contact details.
It’s taken me a lot of time and effort to put this report together, free for VRF loyal subscribers. But there’s no rest for the wicked, as I’m already hard at work on my next report, concerning the insurance coverage, and price tag of novel vitiligo therapies. (Spoiler alert: it won’t be cheap.)
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 firstname.lastname@example.org
"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.
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