pdufa.bio

LINZESS (Iinaclotide)

Updated ยทnext FDA decision on the calendar

LINZESS (Iinaclotide) 2 FDA decisions on record below. Every date links its source.

ABBV catalyst hub · IRWD catalyst hub

About this program

We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · May 27, 2026 ✓ ApprovedABBVPDUFA · May 27, 2026 ✓ ApprovedIRWD

Questions

When is LINZESS (Iinaclotide)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for LINZESS (Iinaclotide); 2 FDA decisions are on record below.

What happened at LINZESS (Iinaclotide)'s most recent FDA decision?

On May 27, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.