Key Points:
- Takeda Zasocitinib shows strong results in late-stage psoriasis trials, outperforming placebo and apremilast.
- AI-discovered oral pill offers a convenient alternative to injections and topicals.
- Could earn up to $5B annually, helping Takeda offset Entyvio’s upcoming generic losses.
Takeda Pharmaceutical says its once-daily Takeda Zasocitinib pill proves safe and effective in late-stage trials, boosting hopes for an oral treatment for the chronic disease and helping the drugmaker counter looming revenue pressure.
Takeda announced Thursday that patients with moderate-to-severe plaque psoriasis who took Zasocitinib showed significantly clearer skin than those given a placebo or the existing oral therapy apremilast. The company says it plans to submit trial data to U.S. and international regulators beginning in fiscal year 2026.
The results mark a milestone for Takeda as it seeks new growth drivers ahead of expected generic competition for Entyvio, its blockbuster ulcerative colitis drug. Psoriasis, an incurable autoimmune disorder, affects more than 125 million people worldwide and often requires lifelong treatment.
“Takeda Zasocitinib has the potential to change the treatment experience for patients who prefer an effective oral option,” Takeda said in a statement, adding that safety results were consistent with earlier studies.
Trial Results Position Drug as Oral Alternative
Psoriasis treatments have long been dominated by topical ointments and injectable antibody drugs. Oral options exist but remain limited, particularly for patients with moderate-to-severe disease.
Takeda Zasocitinib met all primary endpoints in late-stage trials, with patients experiencing greater skin clearance than those receiving placebo or apremilast, a commonly prescribed pill. The company did not disclose detailed efficacy percentages but described the results as statistically and clinically meaningful.
If approved, the drug would join a small but growing class of oral psoriasis therapies, offering an alternative for patients unwilling or unable to use injections. Analysts say convenience and comparable effectiveness could support strong uptake in a competitive market.
The company plans to present full trial data at upcoming medical conferences and submit regulatory applications starting next year.
Artificial Intelligence Speeds Drug Discovery
Takeda Zasocitinib, also known as TAK-279, stands out for its origins. The drug was discovered with the help of artificial intelligence, which narrowed thousands of potential molecules to a small group suitable for testing.
“Algorithms allowed us to rapidly identify promising compounds from a vast chemical space,” said Jeb Keiper, chief executive officer of Nimbus Therapeutics, which originally developed the drug. “What once took years can now happen in a fraction of the time.”
Takeda acquired the therapy from Boston-based Nimbus in 2023, paying $4 billion upfront and agreeing to as much as $2 billion in milestone payments. The deal reflected growing interest among large drugmakers in AI-driven research as a way to cut development time and cost.
Industry experts say the success of Zasocitinib could encourage broader adoption of artificial intelligence in drug discovery, particularly for complex immune-mediated diseases.
Market Potential and Revenue Impact
The global psoriasis treatment market was valued at $27 billion in 2024 and is projected to reach $58 billion by 2032, according to research firm Fortune Business Insights. Growth is driven by rising diagnosis rates and demand for more convenient therapies.
Takeda Zasocitinib could generate about $5 billion in peak annual sales if approved for psoriasis and expanded into other inflammatory diseases, including inflammatory bowel disease, said Stephen Barker, an analyst at Jefferies Japan.
“For Takeda, this asset is strategically important as Entyvio approaches loss of exclusivity,” Barker said. “A successful oral therapy with broad indications could meaningfully offset that decline.”
Takeda says further studies are underway to evaluate Takeda Zasocitinib’s additional conditions, signaling its ambition to make Zasocitinib a cornerstone of its future immunology portfolio.
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