Drugs / Praliciguat
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03818295 | Mar → Apr 2019 | — | Cyclerion Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03499106 | Apr → Jul 2018 | — | Cyclerion Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02616861 | Nov 2015 → May 2016 | — | Cyclerion Therapeutics | Completed | No outcome recorded |
| Phase 25 trials · 2 missed | ||||||
| Phase 2 | NCT07268638 | Dec 2025 → Jun 2027 expected | focal segmental glomerulosclerosis | Akebia Therapeutics | Recruiting | No outcome recorded |
| Phase 2 | NCT03254485 | Nov 2017 → Aug 2019 | diastolic heart failure | Akebia Therapeutics | Completed | Missed primary |
| Phase 2 | NCT03217591 | Aug 2017 → Aug 2019 | diabetic kidney disease | Akebia Therapeutics | Completed | Missed primary |
| Phase 2 | NCT03091920 | Feb → Aug 2017 | hypertensive disorder, type 2 diabetes mellitus | Cyclerion Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT02906579 | Sep 2016 → Mar 2017 | hypertensive disorder, type 2 diabetes mellitus | Cyclerion Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2018-09-13 | Ironwood Pharmaceuticals, Inc. | Regulatory Ironwood Pharmaceuticals Announces FDA Fast Track Designation for Praliciguat for the Treatment of Heart Failure with Preserved Ejection Fraction (HFpEF) ironwoodpharma.com ↗
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotech company, today announced that the U.S. Food and Drug Administration ( FDA ) has granted Fast Track Designation for praliciguat (IW-1973) for the treatment of patients with heart failure with preserved ejection fraction (HFpEF). |
| 2018-06-23 | Ironwood Pharmaceuticals, Inc. | Results Ironwood Presents Praliciguat Phase IIa Study Data Showing Positive Impact on Metabolic and Cardiovascular Clinical Endpoints at the American Diabetes Association’s 78th Scientific Sessions ironwoodpharma.com ↗ |
| 2017-12-04 | Ironwood Pharmaceuticals, Inc. | Results Ironwood Reports Top-line Phase IIa Data for IW-1973 Demonstrating Positive Cardiovascular, Metabolic and Endothelial Effects ironwoodpharma.com ↗
Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) today announced encouraging top-line results from two Phase IIa studies of IW-1973, Ironwood's lead investigational soluble guanylate cyclase (sGC) stimulator, in patients with type 2 diabetes and hypertension. |
| 2015-07-22 | Ironwood Pharmaceuticals, Inc. | Results Ironwood Progresses sGC Stimulator Platform with Positive Top-Line Phase I Data on IW-1973 ironwoodpharma.com ↗
Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) announced today positive top-line data from a Phase I study of IW-1973, its lead investigational soluble guanylate cyclase (sGC) stimulator. |
All press releases naming this drug 8 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Praliciguat | “A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of Praliciguat (IW-1973) in Healthy Volunteers” NCT03499106 ↗4“AIMS/HYPOTHESIS: Praliciguat (IW-1973), a soluble guanylate cyclase stimulator, amplifies nitric oxide signalling.” PMID 31858186 ↗ Dec 2019 “Praliciguat (IW-1973), a novel soluble guanylate cyclase stimulator” PMID 32105984 ↗ Jan 2020 |
| Known as | IW-1973 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03217591 ↗ |
| Action | Activate | “A Stimulator of Soluble Guanylate Cyclase (sGC)” NCT02616861 ↗ |
| Modality | Small molecule | — CHEMBL4297214 ↗ |
| Route | Oral | “IW-1973 Tablet administered orally” NCT02616861 ↗ |