IW-3300 / Ironwood Pharma - LARVOL DELTA

A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome (clinicaltrials.gov) - P2 | N=98 | Terminated | Sponsor: Ironwood Pharmaceuticals, Inc. | Active, not recruiting ➔ Terminated; Business decision

Trial termination • Interstitial Cystitis • Musculoskeletal Pain • Pain

A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome (clinicaltrials.gov) - P2 | N=98 | Active, not recruiting | Sponsor: Ironwood Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting | N=300 ➔ 98 | Trial completion date: Nov 2025 ➔ Feb 2025 | Trial primary completion date: Oct 2025 ➔ Jan 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Interstitial Cystitis • Musculoskeletal Pain • Pain

Ironwood Pharmaceuticals Reports First Quarter 2024 Results (Businesswire) - "Pipeline Updates...Ironwood is advancing apraglutide...Data from the Phase III STARS study was accepted as a late-breaker oral presentation and will be presented on May 21, 2024 at Digestive Disease Week (DDW) 2024 in Washington D.C...The STARGAZE study will continue through its two-year endpoint, where apraglutide will be re-evaluated for safety and efficacy...Ironwood is currently advancing IW-3300, a guanylate cyclase-C agonist being developed for the potential treatment of visceral pain conditions, such as interstitial cystitis / bladder pain syndrome....and endometriosis. Ironwood is continuing the Phase II proof of concept study in IC/BPS."

Late-breaking abstract • P3 data • Trial status • Acute Graft versus Host Disease • Endometriosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Interstitial Cystitis • Short Bowel Syndrome • Women's Health

PATIENT INFORMED PHASE 2 STUDY ASSESSING IW-3300 INVESTIGATIONAL DRUG FOR INTERSTITIAL CYSTITIS/BLADDER PAIN SYNDROME: ADAPTIVE DESIGN AND BAYESIAN PREDICTIVE PROBABILITY OF SUCCESS ANALYSIS (AUA 2024) - P2 | "The results mayinform future clinical study designs, fostering innovative approaches todrug development. The study is anticipated to provide insight into painrelief and symptom control of IC/BPS and to inform the safety and ef-ficacy of IW-3300 for patients burdened with IC/BPS."

Clinical • P2 data • Gastrointestinal Disorder • Interstitial Cystitis • Musculoskeletal Pain • Pain

Patient Informed Phase 2 Study Assessing IW-3300 Investigational Drug for Interstitial Cystitis/Bladder Pain Syndrome: Adaptive Design and Bayesian Predictive Probability of Success Analysis (AUA 2024) - No abstract available

Clinical • P2 data • Interstitial Cystitis • Musculoskeletal Pain • Pain

Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Ironwood Pharmaceuticals, Inc.

Trial completion date • Interstitial Cystitis • Musculoskeletal Pain • Pain

Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Ironwood Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Interstitial Cystitis • Musculoskeletal Pain • Pain

Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Ironwood Pharmaceuticals, Inc.

New P2 trial • Interstitial Cystitis • Musculoskeletal Pain • Pain

A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Ironwood Pharmaceuticals, Inc. | Recruiting ➔ Completed

Trial completion • Solid Tumor

A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Ironwood Pharmaceuticals, Inc. | Recruiting ➔ Completed | N=27 ➔ 18

Enrollment change • Trial completion

A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: Ironwood Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

COLON-TARGETED DELIVERY OF GUANYLATE CYCLASE-C AGONIST IW-3300 RELIEVES COMORBID CHRONIC PELVIC AND SOMATIC PAIN IN A RAT MODEL OF EARLY LIFE STRESS-INDUCED COLONIC HYPERSENSITIVITY (DDW 2022) - "Conclusion S: Here we provide preclinical evidence that delivery of IW-3300 to the colorectal region inhibits overlapping chronic pelvic and somatic pain in an established rodent model of ELS-induced colonic hypersensitivity. These data suggest colonic IW-3300 has the potential to help manage abdominopelvic visceral and somatic pain in patients with DGBI and related visceral pain disorders."

Preclinical • Gastrointestinal Disorder • Gynecology • Immunology • Musculoskeletal Pain • Pain

"$IRWD Ironwood Pharmaceuticals to Present New IW-3300 and Linaclotide Data at Digestive Disease Week® 2022 https://t.co/dqoHpn5cHA" (@stock_titan)

Gastroenterology • Gastrointestinal Disorder

A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Ironwood Pharmaceuticals, Inc.

New P1 trial

Ironwood Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Results; LINZESS® (linaclotide) Achieves Blockbuster Status as U.S. Net Sales Exceed $1 Billion in 2021 (Businesswire) - "Ironwood Pharmaceuticals, Inc...today reported its fourth quarter and full year 2021 results....Ironwood initiated a clinical study for its IW-3300 program in the first quarter of 2022 to evaluate the safety and tolerability of IW-3300 in healthy volunteers."

Trial status • Endometriosis • Women's Health

A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Ironwood Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Ironwood Pharmaceuticals, Inc.

Clinical • New P1 trial

Ironwood Pharmaceuticals Reports Third Quarter 2021 Results and Provides Corporate Development Update (Businesswire) - "Ironwood Pharmaceuticals, Inc...today reported financial results for third quarter 2021....IW-3300 is in pre-clinical development. Ironwood remains on track with the Investigational New Drug ('IND') application to the U.S. FDA this year and the start of the clinical program in the first quarter of 2022."

IND • New trial • Endometriosis • Women's Health

[VIRTUAL] Guanylate Cyclase-C Agonist IW-3300 Attenuates Chronic Colonic and Bladder Hypersensitivity in a Rat Model of Pelvic Radiation Injury (AUA 2021) - "Irradiation of the pelvic region induces persistent colonic and bladder hypersensitivity in adult male rats that was significantly attenuated by IW-3300 treatment. These results suggest IW-3300 has the potential to help manage radiation-induced visceral hypersensitivity and support the further evaluation of IW-3300 in humans for this indication."

Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Oncology • Pain