Drug

Itacitinib

As of the edition of 20 October 2026, Itacitinib is a small molecule: in active development; acts on JAK1.

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

The drug

Status
Active, 2026
Kind
Small molecule
Registered trials
54, 22 stopped early
Disease areas
Cancer; Blood and lymph; Immune system; Lungs and airways; Skin and connective tissue; Digestive system

US protection

No US approval on record.

With no US approval on record there are no listed US patents or exclusivities.

This is the US only.

Companies that need a new molecule because of this drug

1 company on route B and 1 company on route A because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Itacitinib.

Companies on route A for this drug

In the product

1 company is on route A because of Itacitinib.

Target

GeneProteinUniProt
JAK1Tyrosine-protein kinase JAK1P23458

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated2000
Phase 114716
Phase 23613715
Phase 32101
All trials54

Who ran its trials

CompanyRoleYears
SCRI Development InnovationsLead sponsor of trials2020 to now
Innovent BiologicsLead sponsor of trials2020 to now
IncyteLead sponsor of trials