balsalazide
Trade name: colazal
Approved
Jul 18, 2000
Balsalazide, a prodrug that is enzymatically cleaved by bacterial azoreduction to release equimolar quantities of mesalamine (5-aminosalicylic acid or 5-ASA) in the colon, an anti-inflammatory drug. The mechanism of action of 5-ASA is unknown, but appears to be local to the colonic mucosa rather than systemic. Balsalazide is indicated for the treatment of mildly to moderately active ulcerative colitis. Most frequently reported adverse events are: headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, and arthralgia. The use of orally administered antibiotics could, theoretically, interfere with the release of mesalamine in the colon. — NCATS
Clinical trial activity
7 trials · 5 clinical orgs · 11 marketing orgs
Earliest trial started Jan 1, 2004 (NCT00618228)
Timeline
2000s
- Jul 18, 2000
Salix — Earliest FDA Approval
- Jul 18, 2000
Salix — NDA Organization
- Jul 18, 2000
Bausch Health Companies — NDA Secondary Org
- Jan 1, 2004
- Jan 1, 2005
Bausch Health Companies — Earliest Phase 3 Sponsor(trial)
- Dec 28, 2007
Apotex — Marketing Organization
- Dec 28, 2007
Mylan — Marketing Organization
- Dec 28, 2007
West-Ward Pharmaceutical — Marketing Organization
- Dec 28, 2007
Hikma — Marketing Organization
- Dec 28, 2007
Dash Pharms — Marketing Organization
2010s
- Sep 8, 2015
Par Pharmaceuticals — Marketing Organization
- Sep 8, 2015
Strides Pharma Science — Marketing Organization
- Dec 28, 2016
Lupin — Marketing Organization
2020s
- Jun 8, 2023
Zydus Discovery DMCC — Marketing Organization
Indications
Approved for
Mechanism of action
PPARG agonist
- Arachidonate 5-lipoxygenaseINHIBITOR
ALOX5 inhibitor
- CyclooxygenaseINHIBITOR
Cyclooxygenase inhibitor
Approval history
- approvedJul 18, 2000
Chemistry & pharmacology
SMILES
O=C(O)CCNC(=O)c1ccc(/N=N/c2ccc(O)c(C(=O)O)c2)cc1- Mol. weight
- 357.32 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL1201346 ↗
- WikipediaBalsalazide ↗
- NCATSP80AL8J7ZP ↗
- ChEMBLCHEMBL1200760 ↗
Also known as
- 3-(2-{4-[(2-carboxyethyl)carbamoyl]phenyl}hydrazinylidene)-6-oxocyclohexa-1,4-diene-1-carboxylic acid
- 3-(2-{4-[(2-carboxyethyl)carbamoyl]phenyl}hydrazinylidene)-6-oxocyclohexa-1,4-diene-1-carboxylic acid
- 5-[4-(2-carboxy-ethylcarbamoyl)-phenylazo]-2-hydroxy-benzoic acid
- 5-[4-(2-carboxy-ethylcarbamoyl)-phenylazo]-2-hydroxy-benzoic acid
- 5-(carboxyethylcarbamoyl-4-phenylazo)salicylic acid
- balsalazid
- balsalazida
- balsalazida
- balsalazide
- balsalazide
- balsalazide
- balsalazide
- balsalazide
- balsalazide
- balsalazide
- balsalazide
- balsalazide
- balsalazide
- balsalazide disodium
- balsalazide disodium
- balsalazide disodium
- balsalazide disodium
- balsalazide disodium
- balsalazide disodium
- balsalazide sodium
- balsalazide sodium
- balsalazide sodium
- balsalazido
- balsalazido
- balsalazidum
- balsalazidum
- balsalazine
- balsalazine
- balsalazine
- benzoic acid, 5-((4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxy-, disodium salt
- bx661a
- bx 661a
- bx-661a
- bx-661a
- colazal
- colazal
- colazal
- colazal
- colazide
- colazide
- colazide
- (e)-5-((4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxybenzoic acid
- (e)-5-((4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxybenzoic acid
- (e)-5-({p-[(2-carboxyethyl)carbamoyl]phenyl}azo)-2-salicylic acid
- (e)-5-({p-[(2-carboxyethyl)carbamoyl]phenyl}azo)-2-salicylic acid
- giazo
- giazo
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT00649480 | Phase 1 | Jan 1, 2007 | Mylan, PRACS |
| NCT00486031 | Phase 3 | Oct 1, 2006 | Bausch Health Companies |
| NCT00408174 | Phase 3 | May 1, 2006 | Bausch Health Companies |
| NCT00269438 | Phase 3 | Dec 1, 2005 | Bausch Health Companies |
| NCT00618202 | N/A | May 1, 2005 | Novum Pharmaceutical Research Services, Roxane Laboratories |
| NCT00648531 | Phase 1 | May 1, 2004 | Mylan, PRACS |
| NCT00618228 | N/A | Jan 1, 2004 | Novum Pharmaceutical Research Services, Roxane Laboratories |
Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bausch Health Companies | For profit | 3 | 3 | 1 | 2005 |
| Mylan | For profit | 2 | 2 | 1 | 2004 |
| Novum Pharmaceutical Research Services | For profit | 2 | 0 | 1 | 2004 |
| PRACS | For profit | 2 | 0 | 1 | 2004 |
| Roxane Laboratories | For profit | 2 | 2 | 1 | 2004 |
Marketing (14)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Apotex | For profit | MKTG | Dec 28, 2007 |
| Bausch Health Companies | For profit | NDA2 | Jul 18, 2000 |
| Dash Pharms | For profit | MKTG | Dec 28, 2007 |
| Hikma | For profit | MKTG | Dec 28, 2007 |
| Hikma | For profit | SYN | Dec 28, 2007 |
| Lupin | For profit | MKTG | Dec 28, 2016 |
| Mylan | For profit | MKTG | Dec 28, 2007 |
| Mylan | For profit | SYN | Sep 1, 2015 |
| Par Pharmaceuticals | For profit | MKTG | Sep 8, 2015 |
| Salix | For profit | NDA | Jul 18, 2000 |
| Strides Pharma Science | For profit | MKTG | Sep 8, 2015 |
| West-Ward Pharmaceutical | For profit | MKTG | Dec 28, 2007 |
| Zydus Discovery DMCC | For profit | MKTG | Jun 8, 2023 |
| Zydus Discovery DMCC | For profit | SYN | Jun 8, 2023 |