Drugs / Balsalazide
Balsalazide
also known as
Balsalazide Disodium · Balsalazida · Balsalazide disodium anhydrous · Balsalazide disodium dihydrate · Balsalazide disodium salt dihydrate · Balsalazide sodium · Balsalazine · BX-661A · +4 more
Small molecule targets ALOX5, PPARG via inhibition / activation
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed ulcerative colitis 1 milestone | |||||
| Filed | US (FDA) | — | ulcerative colitis | — | “Salix submitted a New Drug Application to the FDA in July, 2007 seeking approval to market a 1100 mg tablet formulation of balsalazide disodium” eisai.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | COLAZAL | — | 2006-12-20 | fda.gov ↗ |
| Approved | US (FDA) | COLAZAL | — | 2000-07-18 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00649480 | Jan → Feb 2007 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00648531 | May 2004 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT00486031 | Oct 2006 → Apr 2008 | ulcerative colitis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00408174 | May 2006 → Jul 2007 | ulcerative colitis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT01532648 Background | Jan 2012 → Oct 2013 | ulcerative colitis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2023-06-10 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Balsalazide Disodium Capsules USP, 750 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Balsalazide Disodium Capsules USP, 750 mg (USRLD: Colazal Capsules, 750 mg). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-06-10 | Zydus Lifesciences Limited | Zydus receives final approval from the USFDA for Balsalazide Disodium Capsules USP, 750 mg zyduslife.com ↗ |
| 2007-09-05 | Eisai Inc. | Eisai Inc. Enters Exclusive Agreement with Salix Pharmaceuticals, Ltd. to Co-promote “COLAZAL®” for the Treatment of Ulcerative Colitis in the U.S. Market eisai.com ↗ |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Balsalazide | “Colazal®, Colazide® (generic: balsalazide), minimum daily dose ≥6.75 g” NCT01532648 ↗ |
| Known as | Balsalazida | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201346 ↗ |
| Known as | Balsalazide Disodium | “Balsalazide Disodium Capsules 750 mg” NCT00648531 ↗ |
| Known as | Balsalazide disodium anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201346 ↗ |
| Known as | Balsalazide disodium dihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201346 ↗ |
| Known as | Balsalazide disodium salt dihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201346 ↗ |
| Known as | Balsalazide sodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201346 ↗ |
| Known as | Balsalazine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201346 ↗ |
| Known as | BX-661A | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201346 ↗ |
| Known as | Colazal | “Colazal®, Colazide® (generic: balsalazide), minimum daily dose ≥6.75 g” NCT01532648 ↗ |
| Known as | Colazide | “Colazal®, Colazide® (generic: balsalazide), minimum daily dose ≥6.75 g” NCT01532648 ↗ |
| Known as | Giazo | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201346 ↗ |
| Known as | NSC-760046 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201346 ↗ |
| Action | Activate | “Peroxisome proliferator-activated receptor gamma agonist” CHEMBL1201346 ↗ |
| Action | Inhibit | “Arachidonate 5-lipoxygenase inhibitor” CHEMBL1201346 ↗ |
| Modality | Small molecule | — CHEMBL1201346 ↗ |
| Route | Oral | “single, oral 2250 mg (3 x 750 mg) dose administration under fasting conditions” NCT00648531 ↗ |
| Target | ALOX5 | “Arachidonate 5-lipoxygenase inhibitor” CHEMBL1201346 ↗ |
| Target | PPARG | “Peroxisome proliferator-activated receptor gamma agonist” CHEMBL1201346 ↗ |