insulin lispro
Trade name: humalog
Approved
Jun 14, 1996
Insulin lispro, sold under the brand name Humalog among others, is a modified type of medical insulin used to treat type 1 and type 2 diabetes. It is delivered subcutaneously either by injection or from an insulin pump. Onset of effects typically occurs within 30 minutes and lasts about 5 hours. Often a longer-acting insulin like insulin NPH is also needed. — Wikipedia
Clinical trial activity
573 trials · 187 clinical orgs · 4 marketing orgs
Earliest trial started Dec 1, 1989 (NCT00410033)
Timeline
1990s
- Jan 1, 1995
Novo Nordisk — Earliest Phase 1 Sponsor(trial)
- Jun 14, 1996
Eli Lilly — Earliest FDA Approval
- Jun 14, 1996
Eli Lilly — NDA Organization
- Jan 1, 1997
Novo Nordisk — Earliest Phase 2 Sponsor(trial)
- Jan 1, 1997
Novo Nordisk — Earliest Phase 3 Sponsor(trial)
2000s
- Jun 7, 2000
Novo Nordisk — NDA Secondary Org
2010s
- May 26, 2015
Eli Lilly — NDA Secondary Org
- Sep 25, 2015
Novo — NDA Secondary Org
- Dec 11, 2017
Sanofi-Aventis — NDA Secondary Org
Indications
Approved for
Studied for
- Alzheimer Disease · Phase 1/Phase 2
- Arteriosclerosis · Phase 4
- Asthma · Phase 3
- Atherosclerosis · Phase 4
- Cardiovascular Diseases · Phase 3
- Cognition · Phase 4
- Cognition Disorders · Phase 2
- Cognitive Dysfunction · Phase 1
- Coronary Artery Disease · Phase 4
- Coronary Disease · Phase 3
- Critical Illness · Phase 4
- Cystic Fibrosis · Phase 3
- Delivery, Obstetric · Phase 1
- Diabetes, Gestational · Phase 4
- Diabetes Mellitus, Type 1 · Phase 4
- Diabetes Mellitus, Type 2 · Phase 4
- Diabetic Nephropathies · Phase 4
- Diabetic Retinopathy · Early Phase 1
- Diet Therapy · Phase 2
- Dry Eye Syndromes · Phase 3
- Endocrine System Diseases · Phase 2
- Fibrosis · Phase 4
- General Surgery · Phase 2
- Glucose Metabolism Disorders · Phase 2
- Healthy Volunteers · Phase 4
- Hepatic Insufficiency · Phase 1
- Hospitalization · Phase 4
- Hypercholesterolemia · Phase 3
- Hyperglycemia · Phase 4
- Hypertension · Phase 3
- Hypoglycemia · Phase 4
- Inflammation · Phase 2
- Insulin · Phase 4
- Leukemia · Phase 3
- Lymphoma · Phase 3
- Metabolic Diseases · Phase 2
- Myocardial Infarction · Phase 4
- Pharmacological and Toxicological Phenomena · Phase 2
- Pulmonary Disease, Chronic Obstructive · Phase 3
- Renal Insufficiency, Chronic · Phase 3
- Sjogren's Syndrome · Phase 3
- Ventricular Dysfunction · Phase 4
Mechanism of action
- Insulin receptorAGONIST
INSR agonist
- Insulin-like growth factor I receptorSupplementation
IGF1R supplementation
Combination products
humalog mix 50/50 kwikpen
with insulin human
Also known as humalog mix, humalog mix 50/50 pen, humalog mix 75/25 kwikpen, humalog mix 75/25 pen, novolog mix, novolog mix 70/30 flexpen, novolog mix 70/30 penfill
ryzodeg
with insulin degludec
Approval history
- approvedJun 14, 1996
Chemistry & pharmacology
SMILES
CCC(=O)O[C@@](Cc1ccccc1)(c1ccccc1)[C@@H](C)CN(C)C.O=S(=O)(O)c1ccc2ccccc2c1- Mol. weight
- 547.72 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaInsulin lispro ↗
- ChEMBLCHEMBL1593906 ↗
- ChEMBLCHEMBL1201664 ↗
- ChEMBLCHEMBL1201611 ↗
- ChEMBLCHEMBL1201538 ↗
- ChEMBLCHEMBL1201496 ↗
- NCATSGFX7QIS1II ↗
- ChEMBLCHEMBL2108569 ↗
- NCATSD933668QVX ↗
Also known as
- 29866
- 29866
- aspart
- aspart
- aspart insulin
- aspart insulin
- aspart insulin
- b28-aspart-insulin
- b28-asp-insulin
- b28-asp-insulin
- biasp30
- biasp30
- biasp30
- biasp 30
- biod-123
- biphasic insulin aspart 30
- biphasic insulin aspart 30:70
- humalog
- humalog
- humalog
- humalog
- humalog kwikpen
- humalog kwikpen
- humalog lispro
- humalog pen
- ina-x14
- ina-x14
- ina-x14
- ins humalog
- ins novorapid
- insulin apart
- insulin aspart
- insulin aspart
- insulin aspart
- insulin aspart
- insulin aspart
- insulin aspart
- insulin aspart
- insulin aspart
- insulin aspart protamine
- insulin aspart protamine
- insulin aspart protamine
- insulin aspart protamine
- insulin aspart protamine
- insulin aspart protamine
- insulin aspart protamine crystalline
- insulin aspart protamine recombinant
- insulin aspart protamine recombinant
- insulin aspart recombinant
- insulin aspart recombinant
- insulin aspart recombinant
- insulin aspart recombinant
- insulin aspart recombinant
- insulin, asp(b28)
- insulin lispro
- insulin lispro
- insulin lispro
- insulin lispro
- insulin lispro
- insulin lispro
- insulin lispro
- insulin lispro
- insulin lispro (genetical recombination)
- insulin,lispro,human/rdna
- insulin lispro protamine
- insulin lispro protamine
- insulin lispro protamine
- insulin lispro protamine
- insulin lispro protamine
- insulin lispro protamine
- insulin,lispro,protamine/rdna
- insulin lispro protamine recombinant
- insulin lispro protamine recombinant
- insulin lispro (rdna origin)
- insulin lispro recombinant
- insulin lispro recombinant
- insulin lispro recombinant
- insulin lispro recombinant
- insulin peglispro
- insulin peglispro
- insulin peglispro
- insulin x14
- insulin x14
- insulin x14
- levopropoxyphene napsylate
- levopropoxyphene napsylate
- levopropoxyphene napsylate anhydrous
- levopropoxyphene napsylate anhydrous
- liprolog
- lispro insulin
- ly2605541
- ly2605541
- ly900014
- novolog
- novolog
- novolog
- novolog
- novolog
- novolog flexpen
- novolog flexpen
- novolog innolet
- novolog innolet
- novolog mix 70:30
- novolog penfill
- novolog penfill
- novomix
- novomix
- novomix 30
- novorapid
- novorapid
- novorapid
- novrad
- novrad
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07165652 | Phase 1 | Oct 13, 2025 | Xentria, Inc. |
| NCT07171684 | N/A | Oct 1, 2025 | Rutgers University |
| NCT07109245 | Phase 4 | Sep 1, 2025 | The Physicians' Services Incorporated Foundation, University of Toronto |
| NCT06945406 | Phase 1 | May 16, 2025 | Eli Lilly |
| NCT06854861 | Phase 1/Phase 2 (Phase 2) | Apr 1, 2025 | Norwegian University of Science and Technology |
| NCT06600776 | Phase 4 | Oct 6, 2024 | Tel Aviv University |
| NCT06532461 | N/A | Jul 20, 2024 | Steno Diabetes Center Copenhagen |
| NCT06251635 | N/A | Jun 3, 2024 | University of Toronto |
| NCT06280703 | Phase 1 | May 15, 2024 | Eli Lilly |
| NCT06370715 | Phase 4 | Apr 18, 2024 | Cipla, Eli Lilly |
| NCT07257627 | Phase 1 | Apr 17, 2024 | Tonghua Dongbao Pharmaceutical Co.,Ltd |
| NCT06765655 | N/A | Apr 9, 2024 | St. Peter's Hospital, Albany, NY |
| NCT06931041 | Phase 3 | Feb 1, 2024 | University of Valencia |
| NCT06238778 | Phase 2 | Jan 23, 2024 | Diasome Pharmaceuticals, State University of New York, Syracuse |
| NCT05689424 | Phase 1 | Jan 10, 2024 | The Leona M. and Harry B. Helmsley Charitable Trust, University of California, San Diego |
| NCT06046417 | Phase 2/Phase 3 (Phase 3) | Nov 30, 2023 | Juvenile Diabetes Research Foundation, McGill University |
| NCT05893797 | N/A | Oct 5, 2023 | Eli Lilly |
| NCT05660941 | N/A | Mar 1, 2023 | University of Manchester |
| NCT05508061 | N/A | Oct 19, 2022 | Inreda Diabetic B.V., Rijnstate Hospital |
| NCT05462756 | Phase 3 | Aug 11, 2022 | Eli Lilly |
Organizations
Research & Development (187)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novo Nordisk | For profit | 219 | 198 | 5 | 1989 |
| Eli Lilly | For profit | 126 | 114 | 5 | 2001 |
| Profil GmbH | For profit | 37 | 3 | 3 | 2002 |
| Adocia | For profit | 25 | 24 | 2 | 2012 |
| Sanofi | For profit | 23 | 18 | 5 | 2001 |
| Emory University | Academic/Hospital | 15 | 14 | 2 | 2006 |
| Biodel | For profit | 12 | 11 | 3 | 2006 |
| Halozyme Therapeutics | For profit | 11 | 11 | 3 | 2007 |
| Tonghua Dongbao Pharmaceutical Co.,Ltd | For profit | 8 | 5 | 2 | 2015 |
| Aarhus University | Academic/Hospital | 7 | 6 | 4 | 2006 |
| Boehringer Ingelheim | For profit | 7 | 0 | 2 | 2011 |
| MannKind Corp | For profit | 7 | 7 | 3 | 2006 |
| Merck | For profit | 7 | 5 | 3 | 2011 |
| Rush University | Academic/Hospital | 7 | 5 | 2 | 2005 |
| Medical University of Graz | Academic/Hospital | 6 | 5 | 3 | 2008 |
| AstraZeneca | For profit | 5 | 5 | 3 | 2003 |
| Diasome Pharmaceuticals | For profit | 5 | 5 | 1 | 2016 |
| Harvard University | Academic/Hospital | 5 | 2 | 2 | 2014 |
| Medical University of Warsaw | Academic/Hospital | 5 | 5 | 1 | 2011 |
| Geropharm | For profit | 4 | 4 | 2 | 2016 |
Marketing (6)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Eli Lilly | For profit | NDA2 | May 26, 2015 |
| Eli Lilly | For profit | SYN | Jun 14, 1996 |
| Eli Lilly | For profit | NDA | Jun 14, 1996 |
| Novo | For profit | NDA2 | Sep 25, 2015 |
| Novo Nordisk | For profit | NDA2 | Jun 7, 2000 |
| Sanofi-Aventis | For profit | NDA2 | Dec 11, 2017 |