insulin aspart
Trade name: Novolog
Approved
Nov 1, 2001
Insulin aspart, sold under the brand name Novolog, among others, is a modified type of medical insulin used to treat type 1 and type 2 diabetes. It is generally used by injection under the skin but may also be used by injection into a vein. Maximum effect occurs after about 1–3 hours and lasts for 3–5 hours. Generally a longer-acting insulin like insulin NPH is also needed. — Wikipedia
Clinical trial activity
96 trials · 86 clinical orgs · 3 marketing orgs
Earliest trial started Jan 1, 2003 (NCT00118963)
Timeline
2000s
- Nov 1, 2001
Earliest FDA Approval
- Aug 26, 2008
Novo Nordisk — First NDA Organization
- Aug 26, 2008
Novo Nordisk — NDA Secondary Org
- Aug 26, 2008
Novo Nordisk — NDA Organization
2010s
- Jan 1, 2012
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2017
Biocon Limited — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2017
Earliest Phase 3 Sponsor(trial)
2020s
- Feb 14, 2025
Sanofi-Aventis — Marketing Organization
- Jul 15, 2025
Biocon Limited — Marketing Organization
Indications
Approved for
Studied for
- Blood Glucose · Phase 4
- Cystic Fibrosis · Phase 4
- Diabetes, Gestational · Early Phase 1
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 1 · Phase 4
- Diabetes Mellitus, Type 2 · Phase 4
- Endothelial Cells · Early Phase 1
- Endothelium, Vascular · Early Phase 1
- Exercise · Phase 2
- Healthy Volunteers · Phase 1
- Hyperglycemia · Phase 4
- Hyperkalemia · Phase 4
- Insulin · Phase 2
- Liver Cirrhosis · Phase 3
- Olfaction Disorders · Phase 1
- Oxidative Stress · Early Phase 1
- Pharmacokinetics · Phase 2/Phase 3
- Pregnancy Complications · Phase 3
- Sedentary Behavior · Early Phase 1
- Taste Disorders · Phase 1
Mechanism of action
- IGF-like family receptor 1AGONIST
IGFLR1 agonist
Approval history
- approvedNov 1, 2001
Chemistry & pharmacology
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaInsulin aspart ↗
Also known as
- aspartame insulin
- insulin aspart / insulin degludec
- insulin biasp30
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07076199 | Phase 3 | Aug 11, 2025 | Novo Nordisk |
| NCT07068295 | Phase 1 | Jul 11, 2025 | Novo Nordisk |
| NCT06809621 | Phase 1 | Jan 29, 2025 | Novo Nordisk |
| NCT06547619 | Early Phase 1 (Phase 1) | Sep 30, 2024 | University of Iowa |
| NCT06492226 | Phase 1 | Jul 30, 2024 | Xentria, Inc. |
| NCT06532461 | N/A | Jul 20, 2024 | Steno Diabetes Center Copenhagen |
| NCT06558708 | Phase 2 | Jun 28, 2024 | Gan and Lee Pharmaceuticals, USA |
| NCT06375031 | Phase 1 | May 31, 2024 | Hengrui Therapeutics, Inc. |
| NCT06046417 | Phase 2/Phase 3 (Phase 3) | Nov 30, 2023 | Juvenile Diabetes Research Foundation, McGill University |
| NCT06199505 | Phase 2 | Nov 27, 2023 | Gan and Lee Pharmaceuticals, USA |
| NCT05946798 | Early Phase 1 (Phase 1) | Aug 30, 2023 | University of Iowa |
| NCT05887895 | Phase 1 | May 23, 2023 | Hengrui Therapeutics, Inc. |
| NCT05802862 | Phase 3 | May 1, 2023 | Sunshine Lake Pharma Co., Ltd. |
| NCT06127433 | Phase 4 | Mar 7, 2023 | Sun Yat-Sen University |
| NCT05754424 | Phase 1 | Feb 17, 2023 | Arecor Limited |
| NCT05614089 | Phase 4 | Jan 31, 2023 | The Leona M. and Harry B. Helmsley Charitable Trust, University of Pittsburgh |
| NCT05719961 | Phase 1 | Jan 5, 2023 | Hengrui Therapeutics, Inc. |
| NCT05767255 | Phase 3 | Dec 1, 2022 | Hospital Universitario San Ignacio |
| NCT05641337 | Phase 3 | Oct 1, 2022 | Fudan University |
| NCT05539872 | Phase 2/Phase 3 (Phase 3) | Aug 22, 2022 | Amphastar Pharmaceuticals |
Organizations
Research & Development (86)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novo Nordisk | For profit | 21 | 16 | 4 | 2017 |
| Sanofi | For profit | 7 | 7 | 3 | 2012 |
| McGill University | Academic/Hospital | 6 | 6 | 4 | 2018 |
| Arecor Limited | For profit | 4 | 4 | 1 | 2019 |
| Emory University | Academic/Hospital | 4 | 3 | 3 | 2018 |
| Geropharm | For profit | 4 | 4 | 2 | 2018 |
| Juvenile Diabetes Research Foundation | Academic/Hospital | 4 | 0 | 2 | 2019 |
| Boston University | Academic/Hospital | 3 | 1 | 2 | 2018 |
| Gan and Lee Pharmaceuticals, USA | For profit | 3 | 3 | 2 | 2019 |
| Harvard University | Academic/Hospital | 3 | 2 | 2 | 2018 |
| Hengrui Therapeutics, Inc. | For profit | 3 | 3 | 1 | 2023 |
| Medical University of Warsaw | Academic/Hospital | 3 | 3 | 1 | 2019 |
| Peking University | Academic/Hospital | 3 | 2 | 2 | 2018 |
| Steno Diabetes Center Copenhagen | Academic/Hospital | 3 | 3 | 2 | 2003 |
| University of Iowa | Academic/Hospital | 3 | 3 | 1 | 2021 |
| Aristotle University of Thessaloniki | Academic/Hospital | 2 | 2 | 2 | 2016 |
| Mountain Diabetes and Endocrine Center | Academic/Hospital | 2 | 2 | 1 | 2018 |
| Nanjing Medical University | Academic/Hospital | 2 | 2 | 1 | 2015 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 2 | 0 | 2 | 2020 |
| Northwestern University | Academic/Hospital | 2 | 1 | 2 | 2018 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Biocon Limited | For profit | MKTG | Jul 15, 2025 |
| Novo Nordisk | For profit | NDA2 | Aug 26, 2008 |
| Novo Nordisk | For profit | NDA | Aug 26, 2008 |
| Sanofi-Aventis | For profit | MKTG | Feb 14, 2025 |