rosiglitazone
Approved
May 25, 1999
Rosiglitazone acts as a highly selective and potent agonist at peroxisome proliferator activated receptors (PPAR) in target tissues for insulin action such as adipose tissue, skeletal muscle, and liver. It is FDA approved for the treatment of as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Inhibitors of CYP2C8 (e.g., gemfibrozil) may increase rosiglitazone levels; inducers of CYP2C8 (e.g., rifampin) may decrease rosiglitazone levels. Common adverse reactions include edema, weight gain, and headache. — NCATS
Clinical trial activity
3 trials · 5 clinical orgs · 13 marketing orgs
Earliest trial started Jan 1, 2004 (NCT04148183)
Timeline
1990s
- May 25, 1999
Woodward — Earliest FDA Approval
- May 25, 1999
SmithKline Beecham — NDA Secondary Org
- May 25, 1999
Woodward — Marketing Organization
- May 25, 1999
Woodward — NDA Secondary Org
- May 25, 1999
Woodward — NDA Organization
2000s
- Oct 10, 2002
GlaxoSmithKline — NDA Secondary Org
- Jan 1, 2004
Earliest Phase 2 Sponsor(trial)
- Jan 31, 2007
Watson Pharmaceuticals — Marketing Organization
- Mar 10, 2008
Roxane Laboratories — Marketing Organization
- Mar 10, 2008
Boehringer Ingelheim — Marketing Organization
- Dec 2, 2008
Mylan — Marketing Organization
- Mar 9, 2009
Sandoz — Marketing Organization
- Mar 9, 2009
Novartis — Marketing Organization
- Dec 8, 2009
Hikma — Marketing Organization
2010s
- Jan 25, 2013
Ani Pharmaceuticals — Marketing Organization
- May 7, 2014
Teva — Marketing Organization
- Apr 29, 2016
Dr. Reddy's Laboratories — Marketing Organization
Indications
Approved for
Studied for
Mechanism of action
PPARG agonist
Selective
Combination products
avandamet
with metformin
avandaryl
with glimepiride
Approval history
- approvedPriority reviewMay 25, 1999
Chemistry & pharmacology
SMILES
CN(CCOc1ccc(CC2SC(=O)NC2=O)cc1)c1ccccn1- Mol. weight
- 357.44 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL121 ↗
- WikipediaRosiglitazone ↗
- NCATSKX2339DP44 ↗
- ChEMBLCHEMBL843 ↗
Also known as
- avandamet
- avandamet
- avandamet
- avandamet
- avandaryl
- avandaryl
- avandia
- avandia
- avandia
- avandia
- avandia
- brl49653
- brl 49653
- brl-49653
- brl-49653
- brl-49653
- brl 49653c
- brl 49653c
- brl-49653c
- brl-49653c
- brl-49653-c
- brl-49653-c
- rosiflitazone
- rosigilitazone
- rosigilitazone
- rosiglitazon
- rosiglitazon
- rosiglitazona
- rosiglitazona
- rosiglitazone
- rosiglitazone
- rosiglitazone
- rosiglitazone
- rosiglitazone
- rosiglitazone
- rosiglitazone
- rosiglitazone
- rosiglitazone
- rosiglitazone
- rosiglitazone
- rosiglitazone
- rosiglitazone / glimepiride
- rosiglitazone hcl
- rosiglitazone hydrochloride
- rosiglitazone maleate
- rosiglitazone maleate
- rosiglitazone maleate
- rosiglitazone maleate
- rosiglitazone maleate
- rosiglitazone maleate-metformin hydrochloride combination
- rosiglitazone-metformin combination
- rosiglitazone / metformin hydrochloride,
- rosiglitazonum
- rosiglitazonum
- rosiglizole
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04114136 | Phase 2 | Oct 15, 2019 | University of Pittsburgh |
| NCT03309319 | N/A | Oct 16, 2016 | Fudan University |
| NCT04148183 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2004 | Government of Mexico, Instituto Mexicano del Seguro Social, Universidad de Colima |
Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Fudan University | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Government of Mexico | Government | 1 | 0 | 1 | 2004 |
| Instituto Mexicano del Seguro Social | Government | 1 | 0 | 1 | 2004 |
| Universidad de Colima | Academic/Hospital | 1 | 1 | 1 | 2004 |
| University of Pittsburgh | Academic/Hospital | 1 | 1 | 1 | 2019 |
Marketing (17)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Ani Pharmaceuticals | For profit | MKTG | Jan 25, 2013 |
| Ani Pharmaceuticals | For profit | SYN | Jan 25, 2013 |
| Boehringer Ingelheim | For profit | MKTG | Mar 10, 2008 |
| Dr. Reddy's Laboratories | For profit | MKTG | Apr 29, 2016 |
| GlaxoSmithKline | For profit | NDA2 | Oct 10, 2002 |
| Hikma | For profit | MKTG | Dec 8, 2009 |
| Mylan | For profit | MKTG | Dec 2, 2008 |
| Novartis | For profit | MKTG | Mar 9, 2009 |
| Roxane Laboratories | For profit | MKTG | Mar 10, 2008 |
| Sandoz | For profit | MKTG | Mar 9, 2009 |
| SmithKline Beecham | For profit | NDA2 | May 25, 1999 |
| Teva | For profit | MKTG | May 7, 2014 |
| Teva | For profit | SYN | Apr 1, 2016 |
| Watson Pharmaceuticals | For profit | MKTG | Jan 31, 2007 |
| Woodward | For profit | MKTG | May 25, 1999 |
| Woodward | For profit | NDA2 | May 25, 1999 |
| Woodward | For profit | NDA | May 25, 1999 |