Drug

Brepocitinib

As of the edition of 20 October 2026, Brepocitinib is a small molecule: marketed, first approved in 2026 (US); acts on JAK1 and TYK2; no US protection is listed.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2026
Kind
Small molecule
Brand name
Lisraya
First approved
27 August 2026 (US)
Approvals on record
1 in 1 region
Holder of the most recent approval
Roivant Sciences
Registered trials
26, 0 stopped early
Disease areas
Skin and connective tissue; Immune system; Bones, joints and muscles; Blood and lymph; Digestive system; Eye

US protection

No US protection is listed.

The FDA registers list no drug-substance patent or exclusivity that counts for this drug.

This is the US only.

Companies that need a new molecule because of this drug

3 company-target rows on route B because of this drug.

Companies on route B for this drug

In the product

3 company-target rows are on route B because of Brepocitinib.

Targets

GeneProteinUniProt
JAK1Tyrosine-protein kinase JAK1P23458
TYK2Non-receptor tyrosine-protein kinase TYK2P29597

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 19900
Phase 2131300
Phase 34130
All trials26

Who has held its approvals

CompanyRoleYears
Roivant SciencesOriginator and Lead sponsor of trials2022 to now