FDA grants priority review to Takeda’s zasocitinib, a computationally designed TYK2 inhibitor, with a decision due Q1 2027
Event confirmedAwaiting review
The takeaway
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.
Status
- Claim
Event confirmedAwaiting review
- Our reporting
- High confidence
- Verification
- Unverified claim
- Importance
- 3 of 5
- Last verified
- 29 September 2026
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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.’
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.
What is disputed or not yet verified
| Verification | Phase 3 randomized trials; FDA review pending |
|---|
Sources
4 sources from 4 sites. Numbers match the chips in the text.
4 sources: 1 primary, 2 press, 1 reaction
Primary
- Takeda: FDA accepts zasocitinib NDA with priority reviewtakeda.com, official
Press
- PharmaVoice: Nimbus used AI to help develop Takeda’s $4B psoriasis betpharmavoice.com, press
- BioSpace: Takeda’s $4B Nimbus bet pays off with best-in-class Phase III databiospace.com, press
Reactions
- IntuitionLabs: AI drug discovery FDA approvals, 2026 reality checkintuitionlabs.ai, discussion
Changes
- Filed