Q&A: Zasocitinib's Role Beyond Topicals in Moderate to Severe Psoriasis

The US Food and Drug Administration (FDA) accepted a New Drug Application for zasocitinib (TAK-279), an investigational once-daily oral tyrosine kinase 2 (TYK2) inhibitor, for adult patients with moderate-to-severe plaque psoriasis, Takeda announced on September 14, 2026.¹ The application received Priority Review, with a Prescription Drug User Fee Act target action date in the first quarter of 2027.¹ Additionally, the European Medicines Agency accepted a marketing authorization application.¹

The filing followed the phase 3 LATITUDE PsO 3001 and 3002 analyses, which enrolled 693 and 1108 adults across 21 countries and compared zasocitinib with placebo and apremilast.¹ At Week 16, 71% of patients in 3001 and 69% in 3002 reached a static Physician Global Assessment (sPGA) score of 0 or 1 with zasocitinib (P < .001 vs placebo).¹˒² Response rates were 32% and 30% with apremilast and 11% and 13% with placebo.¹˒²

Psoriasis Area and Severity Index (PASI) 75 rates were 76% in 3001 and 71% in 3002 with zasocitinib, compared with 37% and 33% with apremilast and 12% with placebo in both trials.¹˒² PASI 90 rates were 61% and 52% with zasocitinib, 17% and 16% with apremilast, and 5% and 4% with placebo.¹˒²

Takeda reported no new safety signals, with upper respiratory tract infection (10.1%), acne (6.5%) and nasopharyngitis (6.2%) as the most common adverse events across the 2 trials.¹ Raj Chovatiya, MD, PhD, is an associate professor at Rosalind Franklin University Chicago Medical School and founder and director of the Center for Medical Dermatology + Immunology Research in Chicago. During this Q&A interview, Chovatiya discussed where zasocitinib may fit in the psoriasis treatment algorithm and what high clearance rates could mean for patients":

HCPLive: Where do you see zasocitinib fitting into the psoriasis treatment algorithm relative to biologics and other oral options like apremilast?

Raj Chovatiya, MD, PhD: It's an exciting announcement, perhaps one we should have been expecting based on the data we've seen. Your question about whether we need more in psoriasis is a good one, because we have more than a dozen options, obviously a number of biologics. Orals have now started to creep into the landscape beyond even apremilast. We had deucravacitinib a few years ago, which had its own hits and misses, and of course, most recently, icotrokinra as well. When thinking about where treatment options fit, we still continue to struggle with making sure all of our patients with moderate to severe psoriasis are on an appropriate, targeted, advanced therapeutic.

So point number 1, whether it's an injectable or an oral, is that getting somebody to the next step of treatment beyond topicals is key. That is one great place where you're going to see a medication like zasocitinib fit. 2, the debate about oral versus biologic has long slanted toward biologics if it's purely based on efficacy. Now, as we're starting to see newer biologic therapies, both small peptides and next-generation TYK2 inhibitors, there's at least more of a comparative similarity between them in terms of how many patients can get relatively clear. So at least you can offer somebody a different route or option if that's what fits in with their life.

And 3, orals have a certain innate sense in a lot of folks that these medications are very similar to something I've used before. If I'm particularly naive to taking systemic medications for most conditions, this might be a way for me to dip my toe in. So what we hope is that medications like zasocitinib may make more individuals who are just entering the systemic-ready phase, or who have more limited areas that are really burdensome, ready to take a therapy.

HCPLive: How meaningful could high rates of clear or almost clear skin with zasocitinib be from an aesthetic and quality-of-life perspective?

Raj Chovatiya, MD, PhD: Immense. If patients were on the fence before, and a lot of it came down to the idea of having to use a biologic therapy, then the idea of an oral treatment that can offer patients a chance to essentially clear up their skin, get their life back, go about their day-to-day function, and perhaps believe they can be their best aesthetic and cosmetic self, that potential difference you can make in a patient's life is huge. So I think a medication like zasocitinib, with some of those high clearance rates, really speaks to what could be possible and the large gap that still remains in terms of our untreated patient population.

Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Chovatiya previously reported serving as an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Apogee Therapeutics, Arcutis, Argenx, ASLAN Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, FIDE, Formation Bio, Galderma, Genentech, GSK, Incyte, LEO Pharma, L’Oréal, Nektar Therapeutics, Novartis, Opsidio, Pfizer Inc., Regeneron, RAPT, Sanofi, Sitryx, and UCB.

References

1. Takeda Pharmaceutical Company Limited. U.S. FDA accepts new drug application under priority review for Takeda's zasocitinib in moderate-to-severe plaque psoriasis, with potential to redefine oral treatment expectations. Published September 14, 2026. Accessed September 21, 2026. https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/.

2. Gooderham M, et al. Once-daily oral zasocitinib demonstrates rapid and reproducible skin clearance with a consistent safety profile in moderate-to-severe plaque psoriasis: results from two randomized phase 3 trials (LATITUDE-PsO-3001 and 3002). Presented at: 2026 American Academy of Dermatology Innovation Academy; July 16, 2026; New York, NY.