insulin degludec
Trade name: tresiba
Approved
Sep 25, 2015
Insulin degludec (INN/USAN) is an ultralong-acting basal insulin analogue that was developed by Novo Nordisk under the brand name Tresiba. It is administered via subcutaneous injection to help control the blood sugar level of those with diabetes. It has a duration of action that lasts up to 42 hours, making it a once-daily basal insulin, that is one that provides a base insulin level, as opposed to the fast- and short-acting bolus insulins. — Wikipedia
Clinical trial activity
189 trials · 52 clinical orgs · 2 marketing orgs
Earliest trial started Dec 1, 2005 (NCT01865279)
Timeline
2000s
- Jan 1, 2005
Novo Nordisk — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2008
Novo Nordisk — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2009
Novo Nordisk — Earliest Phase 3 Sponsor(trial)
2010s
- Sep 25, 2015
Novo Nordisk — Earliest FDA Approval
- Sep 25, 2015
Novo Nordisk — NDA Organization
- Sep 25, 2015
Novo — NDA Secondary Org
Indications
Approved for
Mechanism of action
- Insulin receptorAGONIST
INSR agonist
- Insulin-like growth factor I receptorSupplementation
IGF1R supplementation
Combination products
ryzodeg
with insulin lispro
xultophy
with liraglutide
Also known as insulin degludec and liraglutide
Approval history
- approvedSep 25, 2015
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 degludec ↗
- NCATS54Q18076QB ↗
- ChEMBLCHEMBL2107869 ↗
Also known as
- (1a-21a),(1b-29b)-insulin (human), 29b-(n6-(n-(15-carboxy-1- oxopentadecyl)-l-gamma- glutamyl)-l-lysine)-
- degludec
- ins tresiba
- insulin aspart / insulin degludec
- insulin degludec
- insulin degludec
- insulin degludec
- insulin degludec
- insulin degludec
- insulin degludec
- insulin degludec
- insulin degludec
- insulin degludec
- insulin degludec
- insulin degludec
- insulin degludec / liraglutide
- nn1250
- nn1250
- nn1250
- tresiba
- tresiba
- tresiba
- tresiba
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07215312 | Phase 2 | Oct 13, 2025 | Eli Lilly |
| NCT07032688 | Phase 1 | Aug 11, 2025 | Hengrui Therapeutics, Inc. |
| NCT07018453 | Phase 2 | Jul 16, 2025 | Hengrui Therapeutics, Inc. |
| NCT06945406 | Phase 1 | May 16, 2025 | Eli Lilly |
| NCT06767748 | Phase 3 | Jan 10, 2025 | Gan and Lee Pharmaceuticals, USA |
| NCT06685185 | Phase 1 | Nov 11, 2024 | Novo Nordisk |
| NCT06559722 | Phase 3 | Aug 31, 2024 | Tonghua Dongbao Pharmaceutical Co.,Ltd |
| NCT06925334 | Phase 4 | May 20, 2024 | Anhui Medical University, Dongyang People's Hospital, Jinhua Central Hospital, Jinhua People's Hospital, Nanchang University, Nantong University, The Central Hospital of Lishui City, Tsinghua University, Wenzhou Medical University, Wuhu City Second People's Hospital, Yiwu Central Hospital |
| NCT06280703 | Phase 1 | May 15, 2024 | Eli Lilly |
| NCT06449703 | Phase 1 | May 6, 2024 | Tonghua Dongbao Pharmaceutical Co.,Ltd |
| NCT06288412 | Phase 1 | Feb 26, 2024 | Novo Nordisk |
| NCT06178874 | N/A | Dec 31, 2023 | Ain Shams University |
| NCT06199505 | Phase 2 | Nov 27, 2023 | Gan and Lee Pharmaceuticals, USA |
| NCT06132126 | Phase 1 | Nov 17, 2023 | Eli Lilly |
| NCT06202079 | Phase 2 | Aug 29, 2023 | Gan and Lee Pharmaceuticals, USA |
| NCT05904743 | Phase 4 | Jun 29, 2023 | Jaeb Center for Health Research, MannKind Corp, University of Washington |
| NCT06056167 | N/A | May 17, 2023 | King Faisal University |
| NCT05802862 | Phase 3 | May 1, 2023 | Sunshine Lake Pharma Co., Ltd. |
| NCT06553248 | Phase 1 | Mar 22, 2023 | Gan and Lee Pharmaceuticals, USA |
| NCT06556641 | Phase 1 | Dec 17, 2022 | Gan and Lee Pharmaceuticals, USA |
Organizations
Research & Development (52)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novo Nordisk | For profit | 127 | 120 | 4 | 2005 |
| Eli Lilly | For profit | 18 | 18 | 3 | 2017 |
| Gan and Lee Pharmaceuticals, USA | For profit | 5 | 5 | 3 | 2022 |
| Sanofi | For profit | 5 | 5 | 1 | 2015 |
| Hengrui Therapeutics, Inc. | For profit | 3 | 3 | 2 | 2021 |
| Ain Shams University | Academic/Hospital | 2 | 2 | 2 | 2019 |
| Emory University | Academic/Hospital | 2 | 2 | 2 | 2018 |
| MannKind Corp | For profit | 2 | 2 | 1 | 2022 |
| Sunshine Lake Pharma Co., Ltd. | For profit | 2 | 2 | 2 | 2021 |
| Tonghua Dongbao Pharmaceutical Co.,Ltd | For profit | 2 | 2 | 2 | 2024 |
| University of Copenhagen | Academic/Hospital | 2 | 2 | 1 | 2015 |
| University of Washington | Academic/Hospital | 2 | 1 | 1 | 2020 |
| Aarhus University | Academic/Hospital | 1 | 0 | 1 | 2015 |
| Anhui Medical University | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Central South University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Chinese University of Hong Kong | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Cornell University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Diasome Pharmaceuticals | For profit | 1 | 1 | 1 | 2019 |
| Dongyang People's Hospital | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Fudan University | Academic/Hospital | 1 | 1 | 1 | 2022 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Novo | For profit | NDA2 | Sep 25, 2015 |
| Novo Nordisk | For profit | NDA | Sep 25, 2015 |