Takeda Pharmaceutical (NYSE:TAK) highlighted late-breaking Phase III data for investigational TYK2 inhibitor zasocitinib in moderate-to-severe plaque psoriasis and outlined its commercial plans during a company presentation tied to the American Academy of Dermatology (AAD) annual meeting.
Company context and upcoming launches
CEO-Elect Julie Kim said Takeda is entering what she described as “a new chapter of growth,” citing three pivotal readouts in the prior year for oveporexton, zasocitinib, and rusfertide. Kim said the company is preparing for three major launches over the next 15 months.
- Oveporexton, an orexin receptor 2 agonist for narcolepsy type 1 (NT1), has an FDA-accepted New Drug Application (NDA) with priority review and an August PDUFA date. Kim said Takeda is positioned for a launch in the second half of the year.
- Rusfertide, a hepcidin mimetic for polycythemia vera (PV), also has an FDA-accepted NDA with priority review and an August PDUFA date. Kim said Takeda expects to launch in the second half of the year.
Phase III design for zasocitinib psoriasis studies
Chinwe Ukomadu, head of Takeda’s Gastrointestinal and Inflammation Therapeutic Area Unit, presented details from two Phase III trials: Latitude PsO 3001 and 3002. Ukomadu described zasocitinib as an investigational next-generation oral TYK2 inhibitor with “more than a million-fold” greater binding selectivity for TYK2 versus JAK1, JAK2, and JAK3, and said it maintains inhibition over 24 hours.
Both studies were randomized, multicenter, double-blind, placebo- and active comparator-controlled trials in adults with moderate-to-severe plaque psoriasis. Co-primary endpoints were SPGA 0/1 and PASI 75 at week 16 versus placebo, with secondary endpoints assessed versus placebo and versus active comparator apremilast at weeks 16 and 24.
Study 3001 enrolled about 690 patients randomized 3:1:1 to zasocitinib 30 mg once daily, apremilast 30 mg twice daily, or placebo. Study 3002 enrolled over 1,100 patients randomized 2:1:1 to the same arms and included a randomized withdrawal component starting at week 40 for patients achieving PASI 75, continuing to week 60. Ukomadu said baseline demographics and disease characteristics were generally balanced; about one-third of patients were biologic-experienced, and 3002 trended toward higher BMI, longer disease duration, and more severe psoriasis.
Efficacy results: rapid onset, deepening response, and durability
Ukomadu said the trials met both co-primary endpoints and “all 44 ranked secondary endpoints.” At week 16 versus placebo, SPGA 0/1 response rates were 71% (3001) and 69% (3002) for zasocitinib compared with 11% and 13% for placebo. PASI 75 response rates were 76% (3001) and 71% (3002) for zasocitinib compared with about 12% for placebo in both studies.
He also emphasized superiority versus apremilast, describing “between week 16 and 24, a twofold difference in efficacy” across both co-primary endpoints. Nominal statistical significance versus placebo was observed as early as week 4, and Ukomadu said quality-of-life improvements (DLQI 0/1) also appeared by week 4, reaching up to 60% of patients by week 24.
On higher thresholds, Ukomadu said PASI 90 reached as high as 69% by week 24, and clear-skin outcomes increased through week 24. By week 24, up to 49% achieved SPGA 0, while up to 42% achieved PASI 100. He noted efficacy continued to improve from week 16 to week 24 and said superiority versus both placebo and active comparator was evident by week 8 on clear-skin measures.
In the randomized withdrawal portion of study 3002, Ukomadu said patients who continued zasocitinib maintained responses through week 60, with SPGA 0/1, PASI 75, and PASI 90 maintained at greater than 90% of their prior response. Patients transitioned to placebo lost response slowly; more than 50% still maintained responses 20 weeks later across endpoints. Ukomadu suggested this could be relevant to real-world missed doses.
Asked about biologic-experienced patients, Ukomadu said subgroup analyses to date did not show differences in efficacy versus other groups, and that the company intends to present more data in the future.
Safety and tolerability
Ukomadu said zasocitinib was “very well tolerated” with no new safety signals relative to earlier Phase IIb findings. Most treatment-emergent adverse events were mild or moderate, with no trends toward laboratory abnormalities in blood counts, liver enzymes, or lipids. The most frequent adverse events were upper respiratory tract infections and nasopharyngitis; acne occurred at a low rate of about 6% and was generally manageable.
He noted a death occurred during the study, which the investigator reported was not related to study drug. On serious adverse events (SAEs), Ukomadu said rates were low and most were related to infections, and that discontinuation rates were similar across zasocitinib, apremilast, and placebo arms. In response to a question, he said there were no cases of rhabdomyolysis in the study and that apremilast dose titration was performed.
Commercial outlook, filings, and market opportunity
Rhonda Pacheco, president of Takeda’s U.S. business unit and U.S. country head, framed psoriasis as a market with unmet need for effective oral options. She said that among roughly 1 million treated moderate-to-severe patients, only 50% are on advanced therapy, with patients often staying on conventional therapies longer to avoid biologics due to injections and other concerns. Pacheco said orals are projected to be the fastest-growing segment, with the number of patients treated with an oral advanced therapy projected to rise from about 100,000 to 300,000 over the next decade.
Pacheco highlighted patient and provider priorities—efficacy, speed, durability, safety, and convenience—arguing zasocitinib’s once-daily dosing and lack of fasting restrictions could reduce adherence barriers. She also pointed to Takeda’s experience commercializing ENTYVIO in inflammatory bowel disease as relevant to payer dynamics and access planning, and said the company is engaging payers, thought leaders, and advocacy groups while building launch readiness.
On market sizing, Pacheco described oral penetration rising from about 10% today to about 22% over the next decade, with growth coming primarily from patients cycling through conventional therapies, plus some switching from injectable biologics for those preferring an oral option.
Pacheco said Takeda believes the combined psoriasis and psoriatic arthritis opportunity for zasocitinib could represent $3 billion to $6 billion in global revenues. She said a U.S. filing is on track for this year with global filings to follow, and Takeda reiterated an expected launch timing in the first half of 2027. The company also said it expects additional readouts and programs, including a head-to-head study versus deucravacitinib in psoriasis, a pediatric study, Phase III in psoriatic arthritis, and Phase II studies in ulcerative colitis and Crohn’s disease anticipated in FY 2026, alongside studies in vitiligo and hidradenitis suppurativa.
About Takeda Pharmaceutical (NYSE:TAK)
Takeda Pharmaceutical Company Limited (NYSE: TAK) is a Tokyo-based, multinational biopharmaceutical company with roots dating back to 1781. The company researches, develops, manufactures and commercializes pharmaceutical and biopharmaceutical products for patients worldwide. Takeda is publicly listed and operates as a fully integrated R&D-driven healthcare company focused on delivering specialty medicines and therapies across a range of therapeutic areas.
Takeda’s main business activities encompass discovery and development of prescription medicines, clinical development and regulatory affairs, manufacturing of small molecules and biologics, and global commercial operations.
