Zasocitinib (TAK-279, TYK2 inhibitor)

Summary

Zasocitinib is a TAK-279, TYK2 inhibitor from Takeda (originated at Nimbus using Schrodinger platform). The source describes it as small molecule. It is being developed for plaque psoriasis. ClinicalTrials.gov lists it at Phase 3 (active not recruiting) under NCT06550076, NCT06973291, NCT06323356. The AI role named in the source is molecule design. Registry records: NCT06550076, Phase 3, active not recruiting, updated Jun 2, 2026; NCT06973291, Phase 3, completed, updated May 1, 2026; NCT06323356, Phase 3, completed, updated Jul 30, 2026. EMA review of the marketing authorisation application started 2026-08-13. FDA decision expected Q1 2027. The latest dated source is from Sep 14, 2026.

Built only from the sources listed on this page.

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Facts

Company

Takeda (originated at Nimbus using Schrodinger platform)

Indication

Plaque psoriasis

Therapeutic area

Immunology and inflammation

Modality

Small molecule

AI role

Molecule design

Phase in the source

Phase 3 completed; NDA accepted by FDA under Priority Review for moderate-to-severe plaque psoriasis (Confirmed, Takeda, 2026-09-14); FDA decision expected Q1 2027 per Takeda, as of Sep 14, 2026

Phase source

Confirmed

Board column

Phase 3

AI evidence

AI source: Paper

“The discovery of zasocitinib was aided by an artificial intelligence-assisted computational design tool”

Source: paper (opens in new tab)

Trial records

• NCT06550076 on ClinicalTrials.gov (opens in new tab) Phase 3 Active not recruiting Updated Jun 2, 2026
• NCT06973291 on ClinicalTrials.gov (opens in new tab) Phase 3 Completed Updated May 1, 2026
• NCT06323356 on ClinicalTrials.gov (opens in new tab) Phase 3 Completed Updated Jul 30, 2026

Also listed: EU CTIS 2025-522586-30-00 and others (13 CTIS records, Takeda).

Milestone timeline

1. May 1, 2026 Registry

   NCT06973291 record updated

   Phase 3, Completed

   NCT06973291 (opens in new tab)

2. Jun 2, 2026 Registry

   NCT06550076 record updated

   Phase 3, Active not recruiting

   NCT06550076 (opens in new tab)

3. Jul 30, 2026 Registry

   NCT06323356 record updated

   Phase 3, Completed

   NCT06323356 (opens in new tab)

4. Aug 13, 2026 Source

   EMA review started

   Marketing authorisation application EMEA/H/C/006796.

   EMA list of medicines under evaluation (opens in new tab)

5. Sep 14, 2026 Source

   Company release: Phase 3 completed; NDA accepted by FDA under Priority Review for moderate-to-severe plaque psoriasis (Confirmed, Takeda, 2026-09-14); FDA decision expected Q1 2027 per Takeda

   EMA review of the marketing authorisation application started 2026-08-13. FDA decision expected Q1 2027.

   Company release (opens in new tab)

6. Oct 16, 2026 Check

   Registry check

   Listed Phase 3 trials are psoriasis studies; many more zasocitinib trials exist.

   NCT06550076 (opens in new tab)NCT06973291 (opens in new tab)NCT06323356 (opens in new tab)