Ironwood Pharmaceuticals, Inc. is a healthcare company, which engages in the development and commercialization of Gastrointestinal (GI) products. It operates through the Human Therapeutics segment. The company was founded on January 5, 1998 and is headquartered in Boston, MA.
Clinical Trials
32
7 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
6
18.8%
Completed
20
62.5%
Not yet recruiting
1
3.1%
Terminated
5
15.6%
No approval data available
- Ironwood Pharmaceuticals reported first quarter 2026 LINZESS U.S. net sales of $272.5 million, a 97% year-over-year increase driven by improved net price and 5% prescription demand growth. - The FDA accepted a supplemental NDA for LINZESS in children aged 2–5 years with functional constipation, with a priority review PDUFA date of May 24, 2026. - Apraglutide's confirmatory Phase III STARS-2 trial is on track for site initiation in Q2 2026, targeting 124 SBS-IF patients with a primary endpoint of relative parenteral support volume change at week 24. - Ironwood reiterated full-year 2026 guidance including LINZESS U.S. net sales of $1.125–$1.175 billion and adjusted EBITDA greater than $300 million.
- The FDA has approved LINZESS (linaclotide) for treating functional constipation in pediatric patients aged 2 years and older, expanding from the previous minimum age of 6 years. - LINZESS remains the only FDA-approved prescription therapy for pediatric functional constipation, a chronic condition affecting an estimated 3% of preschool children worldwide. - The approval was supported by a 12-week Phase 3 randomized, placebo-controlled trial showing improved spontaneous bowel movement frequency with LINZESS 72 mcg compared to placebo. - The drug can be mixed with applesauce or water for easier administration in young children, addressing a significant unmet medical need in this vulnerable population.
- The FDA has approved linaclotide (Linzess) capsules for children aged 7 years and older with irritable bowel syndrome with constipation, marking the first FDA-approved treatment for this condition in pediatric patients. - Approval was based on efficacy data extrapolated from adults with IBS-C, supported by a 12-week clinical trial in children aged 7-17 years that demonstrated consistent clinical benefits. - The recommended dosage is 145 mcg taken orally once daily, with diarrhea being the most frequently reported adverse event in pediatric patients. - The drug is contraindicated in patients younger than 2 years due to risk of serious dehydration and should not be used in those with mechanical gastrointestinal obstruction.
- Cyclerion Therapeutics has secured intellectual property from MIT to relaunch as a neuropsychiatric company focused on treatment-resistant depression affecting 3 million Americans. - The company's lead program combines common anesthetic agents with proprietary technology to restore brain connectivity in patients with treatment-resistant depression. - A Phase 2 proof-of-concept trial is expected to begin in 2026, with initial data anticipated in 2027, marking a strategic shift from the company's previous focus on soluble guanylate cyclase stimulators. - The approach leverages known anesthetic mechanisms paired with intelligent delivery systems to pioneer a new class of neuropsychiatric therapies.
- The NHS in England has approved relugolix combination therapy as the first long-term daily oral treatment for endometriosis, expected to benefit around 1,000 women annually whose symptoms persist despite previous treatments. - Organon discontinued development of OG-6219 after the drug candidate failed its Phase 2 trial in July 2025, despite being acquired for $75 million and previously described as the company's "biggest potential opportunity." - Hope Medicine's HMI-115, a first-in-class monoclonal antibody targeting the prolactin receptor, reported positive interim Phase II results and received Breakthrough Therapy Designation from China's NMPA. - Multiple companies including TiumBio, Lisata Therapeutics, and Gynica are advancing novel therapeutic approaches through various clinical trial phases, representing diverse mechanisms of action for endometriosis pain management.
• A newly released global clinical trials review provides extensive data on Interstitial Cystitis research, tracking trial numbers and enrollment trends across major countries worldwide. • The report categorizes trials by region, phase, status, and sponsorship, highlighting key pharmaceutical companies including Astellas Pharma, AbbVie, Johnson & Johnson, and Pfizer as prominent sponsors. • This comprehensive analysis serves as a strategic resource for stakeholders making investment decisions in IC research, offering insights into trial success rates and identifying optimal locations for clinical studies.
- Ironwood Pharmaceuticals' stock plummeted by 37% after the FDA required a confirmatory Phase 3 trial for apraglutide, a treatment for short bowel syndrome with intestinal failure. - Pharmacokinetic analysis revealed that exposure and dosing in the original STARS Phase 3 trial were lower than intended due to preparation and administration issues. - Despite promising efficacy data showing 27 patients achieving enteral autonomy in the long-term extension trial, the company has engaged Goldman Sachs to explore strategic alternatives.
• Ironwood Pharmaceuticals has announced that a confirmatory Phase 3 trial will be required for apraglutide in short bowel syndrome with intestinal failure, following its $1 billion acquisition of VectivBio. • The GLP-2 analogue apraglutide was positioned as a potential blockbuster drug with projected annual sales of $1 billion, offering advantages over existing treatments like Takeda's Gattex through improved potency and weekly dosing. • Ironwood has engaged Goldman Sachs to explore strategic alternatives for the company while continuing the long-term extension study and working with the FDA on the design of the confirmatory trial.
• Tenax Therapeutics has appointed Gillian Andor as Vice President of Clinical Operations to support its Phase 3 program for oral levosimendan (TNX-103). • Ms. Andor brings over 20 years of experience in clinical operations, including NDA submissions and approvals, to accelerate the Phase 3 LEVEL study. • Her expertise will be crucial as Tenax Therapeutics advances oral levosimendan for pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF). • The appointment signifies Tenax's commitment to strengthening its clinical development capabilities as it prepares for potential global regulatory filings.
- The FDA approved mirikizumab (Omvoh) for Crohn's disease, marking its second approval in IBD after ulcerative colitis, based on positive Phase 3 trial results. - A tentative FDA approval was granted for a generic version of rifaximin for IBS-D, offering a potential cost-effective alternative pending the resolution of ongoing litigation. - Ironwood initiated a rolling NDA submission for apraglutide, aiming to address short bowel syndrome by reducing dependence on parenteral support. - Research indicates fecal microbiota transplantation (FMT) shows promise in treating type 1 diabetes and gastroenteropathy, improving patient quality of life.
