Ironwood Pharmaceuticals, Inc. IRWD
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD) is a GI/hepatology drug developer. Its lead program, Apraglutide, is in Phase 3 for Short bowel syndrome with intestinal failure (SBS-IF), parenteral support dependency. Its next catalyst on record is Apraglutide: NDA filing for SBS-IF (2029).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Apraglutide — NDA filing for SBS-IF (2029). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| LINZESS (linaclotide) | IBS-C (adults and pediatric ≥7 years), CIC (adults), FC (pediatric 2-17 years) | small molecule | Approved |
| Apraglutide | Short bowel syndrome with intestinal failure (SBS-IF) | protein/peptide | Phase 3 |
| IW-3300 | Interstitial cystitis/bladder pain syndrome (IC/BPS) | small molecule | Phase 2 |
Recent results and decisions
- Nov 5, 2026n/a STARS-2 confirmatory Phase 3 trial of apraglutide in short bowel syndrome with intestinal failure is ongoing with planned U.S. and global site expansion on track.
STARS-2 confirmatory Phase 3 trial of apraglutide in short bowel syndrome with intestinal failure (SBS-IF) is ongoing; Planned U.S. and global site expansion on track
Filing - Aug 6, 2026started Confirmatory Phase 3 STARS-2 of apraglutide initiated and actively recruiting (24-week randomized placebo-controlled; primary endpoint relative change in weekly parenteral support volume).
Confirmatory Phase 3 STARS-2 trial of apraglutide in short bowel syndrome with intestinal failure (SBS-IF) now actively recruiting patients
Filing - Aug 6, 2026approval FDA approved LINZESS in May 2026 for pediatric functional constipation in patients 2 years and older.
In May 2026, the U.S. Food and Drug Administration (FDA) approved the use of LINZESS in pediatric patients 2 years of age and older with functional constipation (FC).
Filing
3 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 GI/hepatology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.