Drugs / Insulin icodec
Insulin icodec
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | AWIQLI FLEXTOUCH | — | 2026-03-26 | fda.gov ↗ |
| Approved | EU (EMA) | Awiqli | — | 2024-05-17 | europa.eu ↗ |
Trials 31 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 115 trials | ||||||
| Phase 1 | NCT07591519 | May 2026 → Jul 2027 expected | — | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06288412 | Feb 2024 → Mar 2025 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT05790681 | Apr 2023 → Feb 2024 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT05435677 | Jun 2022 → Apr 2023 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT04857398 | Apr 2021 → Apr 2022 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT04597697 | Dec 2020 → Mar 2022 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT04582435 | Oct 2020 → Apr 2022 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT04582448 | Oct 2020 → Sep 2021 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT03945656 | May 2019 → Sep 2021 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT03766854 | Dec 2018 → Dec 2019 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT03723772 | Nov 2018 → Jun 2020 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT03723785 | Nov 2018 → Sep 2019 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT02964104 | Nov 2016 → Dec 2017 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT02148861 | May 2014 → Jun 2015 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01809184 | Mar → Sep 2013 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03922750 | May → Dec 2019 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT03951805 | May → Dec 2019 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT03751657 | Nov 2018 → Dec 2019 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT07076199 | Aug 2025 → Jan 2027 expected | type 1 diabetes mellitus | Novo Nordisk A/S | Recruiting | No outcome recorded |
| Phase 3 | NCT06340854 | Apr 2024 → May 2025 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT05813912 | Sep 2023 → Apr 2025 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT05823948 | Apr 2023 → Mar 2024 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT05259033 | Apr 2022 → Dec 2023 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT05013229 | Nov 2021 → Nov 2023 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT04880850 | May 2021 → Jun 2022 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT04848480 | Apr 2021 → Apr 2022 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT04795531 | Mar 2021 → Jun 2022 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT04770532 | Mar 2021 → Jan 2022 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT04760626 | Mar 2021 → Aug 2022 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT04460885 | Nov 2020 → May 2022 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07112339 | Aug 2025 → Aug 2026 overdue | type 2 diabetes mellitus | Novo Nordisk A/S | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07630233 Comparator | Jun → Oct 2026 expected | type 2 diabetes mellitus | The United Bio-Technology (Hengqin) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07165223 Comparator | Oct 2025 → Nov 2026 expected | diabetes mellitus | Gan & Lee Pharmaceuticals. | Recruiting | No outcome recorded |
| Phase 3 | NCT05352815 Comparator | Jun 2022 → Mar 2024 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-07-10 | Novo Nordisk A/S | Novo Nordisk receives Complete Response Letter in the US for once-weekly basal insulin icodec novonordisk.com ↗ |
| 2024-03-21 | Novo Nordisk A/S | Awiqli® (once-weekly basal insulin icodec) recommended for approval for the treatment of diabetes by the European regulatory authorities novonordisk.com ↗ |
| 2022-10-03 | Novo Nordisk A/S | Once-weekly insulin icodec demonstrates superior reduction in HbA1c in combination with a dosing guide app versus once-daily basal insulin in people with type 2 diabetes in ONWARDS 5 phase 3a trial novonordisk.com ↗ |
| 2022-07-29 | Novo Nordisk A/S | Novo Nordisk achieves primary objectives of ONWARDS 3 and 4 trials with once-weekly insulin icodec demonstrating superior reduction in HbA1c vs insulin degludec in ONWARDS 3 novonordisk.com ↗ |
| 2022-06-03 | Novo Nordisk A/S | Novo Nordisk achieves primary objectives of ONWARDS 1 and 6 trials with once-weekly insulin icodec demonstrating superior reduction in HbA1c vs insulin glargine U100 in ONWARDS 1 novonordisk.com ↗ |
| 2022-04-28 | Novo Nordisk A/S | Once-weekly insulin icodec demonstrates superior reduction in HbA1c vs insulin degludec in people with type 2 diabetes in ONWARDS 2 phase 3a trial novonordisk.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 43 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | insulin icodec | “IcoSema is a once-weekly combination therapy of basal insulin icodec (icodec) and semaglutide (a GLP-1 analogue) developed for the treatment of type 2 diabetes.” PMID 40482670 ↗ Jun 202532“IcoSema (a combination therapy of basal insulin icodec and semaglutide)” PMID 39820580 ↗ Jan 2025 |
| Known as | icodec | “AIM: To describe the phase 3a ONWARDS clinical development programme investigating insulin icodec (icodec), a once-weekly basal insulin, including the design and rationale for...” PMID 36106652 ↗ Oct 20227“AIMS: To investigate the efficacy and safety of intensifying once-weekly insulin icodec (icodec) with once-weekly semaglutide in adults with type 2 diabetes (T2D).” PMID 42387310 ↗ Jul 2026 “IcoSema is a once-weekly combination therapy of basal insulin icodec (icodec) and semaglutide (a GLP-1 analogue) developed for the treatment of type 2 diabetes.” PMID 40482670 ↗ Jun 2025 “BACKGROUND AND OBJECTIVE: Icodec is a once-weekly insulin being developed to provide basal insulin coverage in diabetes mellitus.” PMID 38722461 ↗ May 2024 “Insulin icodec (icodec) is a once-weekly basal insulin currently under development” PMID 37148899 ↗ May 2023 “once-weekly insulin icodec (icodec) on glycemic control and safety outcomes” PMID 40040516 ↗ Mar 2025 “Insulin icodec (icodec) is a novel once-weekly basal insulin analog.” PMID 33875485 ↗ Apr 2021 “Once-weekly insulin icodec (icodec) is a basal insulin analogue” PMID 37748181 ↗ Sep 2023 |
| Known as | insulin 287 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01809184 ↗ |
| Known as | NNC0148-0000-0287 | “NNC0148-0000-0287 (insulin 287) in a GIPET® I tablet formulation” NCT01809184 ↗ |
| Action | Activate | “In vitro cell-based studies showed that insulin icodec activates the same dose-dependent IR-mediated signaling and metabolic responses as native human insulin (HI).” PMID 34413118 ↗ Aug 2021 |
| Modality | Protein / enzyme biologic | “Insulin icodec is a basal insulin analogue designed for once-weekly administration that is in development for the treatment of diabetes.” PMID 32960514 ↗ Sep 2020 |
| Route | Oral | “Orally administered insulin 287.” NCT01809184 ↗ |