insulin glulisine
Trade name: Apidra
Recombinant proteinapproved
Approved
Apr 16, 2004
Insulin glulisine, sold under the brand name Apidra among others, is a rapid-acting modified form of medical insulin used for the treatment of diabetes. It differs from human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine in position B29 is replaced by glutamic acid. When injected subcutaneously, it appears in the blood earlier than regular human insulin (RHI). Intravenous injections may be used for extreme hyperglycemia. It was developed by Sanofi-Aventis. — Wikipedia
Clinical trial activity
98 trials · 43 clinical orgs · 2 marketing orgs
Phase 1
12
Phase 2
32
Phase 3
24
Phase 4
47
Earliest trial started Dec 1, 2001 (NCT00290043)
Timeline
Indications
Approved for
Studied for
- Alzheimer Disease · Phase 2
- Atrophy · Phase 4
- Cardiovascular Diseases · Phase 3
- Cognitive Dysfunction · Phase 2
- Diabetes Mellitus, Type 1 · Phase 4
- Diabetes Mellitus, Type 2 · Phase 4
- Diabetic Ketoacidosis · Phase 4
- Diabetic Nephropathies · Phase 4
- Down Syndrome · Phase 1
- Glucagon-Like Peptide 1 · Phase 4
- Glycemic Control · Phase 3
- Healthy Volunteers · Phase 1
- Hyperglycemia · Phase 4
- Liver Cirrhosis · Phase 4
- Myocardial Infarction · Phase 3
Mechanism of action
- Insulin receptorAGONIST
INSR agonist
IGF1R agonist
Approval history
- approvedApr 16, 2004
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaInsulin glulisine ↗
- NCATS7XIY785AZD ↗
- ChEMBLCHEMBL1201613 ↗
Also known as
- apidra
- apidra
- apidra
- apidra solostar
- apidra solostar
- b3-lysyl-b29-glutamylinsulin
- glulisine apidra
- glulisine insulin
- hmr 1964
- hmr-1964
- hmr-1964
- ins apidra
- ins apidra opticlik
- ins apidra optiset
- ins apidra solostar
- insulin apidra
- insulin glulisine
- insulin glulisine
- insulin glulisine
- insulin glulisine
- insulin glulisine
- insulin glulisine
- insulin glulisine
- insulin glulisine
- insulin glulisine
- insulin glulisine (genetical recombination)
- insulin glulisine (rdna origin)
- insulin glulisine [rdna origin]
- insulin glulisine recombinant
- insulin glulisine recombinant
- insulin glulisine recombinant
- insulin glulisine recombinant
- insulin glulisine (recombinant dna origin)
- insulin, lys(b3)-glu(b29)-
- insulin, lysyl(b3)-glutamyl(b29)-
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07070752 | Phase 3 | Apr 14, 2023 | Geropharm |
| NCT04124302 | Phase 4 | Nov 30, 2019 | Medical University of Warsaw |
| NCT04019821 | Phase 4 | Jul 31, 2019 | Medical University of Warsaw |
| NCT03529123 | Phase 3 | Jun 19, 2018 | Sanofi |
| NCT03359837 | Phase 4 | Jan 20, 2018 | Sanofi |
| NCT03260868 | Phase 4 | Sep 22, 2017 | Sanofi |
| NCT03013985 | Phase 4 | May 17, 2017 | Emory University |
| NCT02910518 | Phase 1 | Feb 17, 2017 | Sanofi |
| NCT03328845 | Phase 4 | Jan 31, 2017 | Government of Spain |
| NCT02488616 | Phase 2 | Jan 1, 2017 | University of Montreal |
| NCT02490098 | Phase 2 | Dec 1, 2016 | Juvenile Diabetes Research Foundation, University of Montreal |
| NCT02987751 | Phase 4 | Dec 1, 2016 | India Diabetes Research Foundation |
| NCT02914886 | Phase 4 | Sep 1, 2016 | Gottfried Wilhelm Leibniz Universität Hannover, Sanofi |
| NCT02688933 | Phase 4 | May 5, 2016 | Sanofi |
| NCT02685449 | Phase 4 | Feb 1, 2016 | Medical University of Warsaw, University of Alberta |
| NCT02455076 | Phase 4 | Sep 1, 2015 | Emory University |
| NCT02503501 | Phase 2 | Aug 1, 2015 | HealthPartners Institute |
| NCT02416765 | Phase 2 | May 1, 2015 | University of Montreal |
| NCT02432716 | Phase 1 | Apr 1, 2015 | HealthPartners Institute |
| NCT02276859 | Phase 4 | Oct 1, 2014 | Medical University of Warsaw, University of Alberta |
Showing 20 of 98 trials
Page 1 / 5
Organizations
Research & Development (43)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sanofi | For profit | 63 | 49 | 5 | 2001 |
| Emory University | Academic/Hospital | 8 | 8 | 3 | 2005 |
| Medical University of Warsaw | Academic/Hospital | 5 | 5 | 1 | 2011 |
| Halozyme Therapeutics | For profit | 4 | 4 | 3 | 2009 |
| HealthPartners Institute | Academic/Hospital | 3 | 3 | 2 | 2011 |
| Johannes Gutenburg University | Academic/Hospital | 3 | 1 | 2 | 2006 |
| University of Montreal | Academic/Hospital | 3 | 3 | 1 | 2015 |
| Cairo University | Academic/Hospital | 2 | 2 | 2 | 2010 |
| ikfe GmbH | For profit | 2 | 2 | 1 | 2011 |
| Profil GmbH | For profit | 2 | 1 | 1 | 2007 |
| University of Alberta | Academic/Hospital | 2 | 0 | 1 | 2014 |
| Amylin | For profit | 1 | 0 | 1 | 2007 |
| AstraZeneca | For profit | 1 | 1 | 1 | 2007 |
| Department of Veteran Affairs | Government | 1 | 1 | 1 | 2007 |
| Emek Medical Center | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Free University of Amsterdam | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Geropharm | For profit | 1 | 1 | 1 | 2023 |
| Gottfried Wilhelm Leibniz Universität Hannover | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Government of Spain | Government | 1 | 1 | 1 | 2017 |
| Grady Memorial Hospital, Atlanta | Academic/Hospital | 1 | 0 | 1 | 2006 |
43 organizations
Page 1 / 3
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Aventis | For profit | NDA | Apr 16, 2004 |
| Sanofi-Aventis | For profit | NDA2 | Apr 16, 2004 |