FDA grants priority review to Takeda's zasocitinib, a computationally designed TYK2 inhibitor, with a decision due Q1 2027
Takeda said on 14 Sept 2026 that the FDA had accepted, with priority review, its new drug application for zasocitinib (TAK-279), an oral TYK2 inhibitor for moderate-to-severe plaque psoriasis. The target action date is in Q1 2027. The molecule came from Nimbus Therapeutics and Schrödinger's physics-based (free energy perturbation) and machine-learning design. If approved, it may be called the first approved "AI-designed" drug, a label that Nimbus's own R&D head rejects.
Key facts
- NDA accepted under priority review; PDUFA target action date in the first quarter of calendar 2027
- Phase 3 LATITUDE PsO 3001 (693 patients) and 3002 (1,108 patients): all primary endpoints and all 44 ranked secondary endpoints met; nearly 3,000 patients across the programme
- Head-to-head: statistically superior to BMS's Sotyktu (deucravacitinib); >35% of patients reached PASI 100 at week 16 (per press)
- Identified in 2020 by Nimbus with Schrödinger's FEP + ML; ~13,000 compounds assessed computationally (PharmaVoice)
- Takeda bought it from Nimbus in 2022 for $4B upfront plus up to $2B in sales milestones
- Nimbus R&D president Peter Tummino: 'I have heard people say it's going to be the first AI-approved drug and that's not the term I would use.'
Science result
- Field
- medicine / drug discovery / immunology
- Problem
- Selective allosteric TYK2 inhibition for psoriasis
- Result
- Computationally designed oral TYK2 inhibitor met all Phase 3 endpoints, beat deucravacitinib head-to-head and entered FDA priority review.
- AI system
- Schrödinger FEP+ physics-based platform, machine learning
- Human role
- Human-led medicinal chemistry with physics-based computation and ML
- Verification
- Phase 3 randomized trials; FDA review pending
- Status
- pending
What happened
Takeda's TYK2 inhibitor finished a Phase 3 programme of nearly 3,000 patients and was accepted for FDA priority review, with a decision expected in Q1 2027. The compound was found in 2020 when Nimbus and Schrödinger used free-energy-perturbation physics simulations and machine learning to evaluate about 13,000 designs computationally.
Why it matters
It could become the first FDA-approved drug widely described as computationally or AI-designed, just ahead of Insilico's rentosertib. The label is disputed. The design relied mainly on physics-based modelling and was not generative AI, and the drug was identified in 2020.
Changelog
- 2026-09-29: created
Related events
Sources (4)
- officialTakeda: FDA accepts zasocitinib NDA with priority review
- pressPharmaVoice: Nimbus used AI to help develop Takeda's $4B psoriasis bet
- pressBioSpace: Takeda's $4B Nimbus bet pays off with best-in-class Phase III data
- discussionIntuitionLabs: AI drug discovery FDA approvals, 2026 reality check
id: 2026-09-14-takeda-zasocitinib-fda-priority-review · updated 2026-09-29 · open in the interactive timeline