Data updated: May 26, 2026
AWIQLI FLEXTOUCH (insulin icodec)
Trial Activity: Declining 2 active trials
Metabolic
Approved 2026-03-26
Awiqli is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Source: FDA Label • Novo Nordisk
Development Insights
Novo Nordisk A/S conducting 28 trials (100%)
5 indications explored (Moderate)
→ diabetes mellitus, type 2 (22 trials)
→ diabetes mellitus, type 1 (4 trials)
→ diabetes (2 trials)
1
Indication
--
Phase 3 Trials
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-03-26
- Routes
- SOLUTION
- Dosage Forms
- INJECTION
AWIQLI FLEXTOUCH Approval History
Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
What AWIQLI FLEXTOUCH Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
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Clinical Trial Registry
28 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05823948 ONWARDS 9 results posted | NN1436-4909 U1111-1271-9296 | Ph 3 | completed | A Study Using Flash Glucose Measurements for a New Once-weekly Insulin (Insulin Icodec) in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 9) |
| NCT05790681 | NN1436-4888 U1111-1271-9231 | Ph 1 | completed | A Study to Test How New Long-acting Insulin (Insulin Icodec) Works in the Body of Children and Teenagers |
| NCT06340854 | NN1436-7724 U1111-1292-6151, 2023-506084-34 | Ph 3 | completed | A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes |
| NCT05813912 | NN1436-4910 2022-002847-24, U1111-1281-4752 | Ph 3 | completed | A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes |
| NCT07112339 | NN1436-7727 U1111-1302-4943, 2024-520068-32 | Ph 4 | recruiting | A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults With Type 2 Diabetes |
| NCT07076199 ONWARDS 11 | NN1436-8182 U1111-1310-7017, 2024-519945-31 | Ph 3 | recruiting | A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes |
| NCT04770532 ONWARDS 2 results posted | NN1436-4478 U1111-1247-4945, 2020-000454-10 | Ph 3 | completed | A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin |
| NCT04460885 ONWARDS 1 results posted | NN1436-4477 U1111-1247-3878, 2020-000442-34 | Ph 3 | completed | A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before |
| NCT04880850 ONWARDS 4 results posted | NN1436-4480 U1111-1247-5269, 2020-000474-16 | Ph 3 | completed | A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4) |
| NCT04848480 ONWARDS 6 results posted | NN1436-4625 U1111-1251-7315, 2020-002374-27 | Ph 3 | completed | A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6) |
| NCT05352815 COMBINE 1 results posted | NN1535-4591 U1111-1260-8259, 2020-005281-34 | Ph 3 | completed | A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec |
| NCT04760626 ONWARDS 5 results posted | NN1436-4481 U1111-1247-5279, 2020-000476-38 | Ph 3 | completed | A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before |
| NCT06288412 | NN1436-7615 U1111-1285-1665, 2023-505012-38 | Ph 1 | completed | A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fasting |
| NCT05435677 | NN1535-4710 U1111-1262-1959 | Ph 1 | completed | A Research Study to Look at How Insulin Icodec and Semaglutide Work in the Body of People From China With Type 2 Diabetes When Given Alone or Together |
| NCT03723772 | NN1436-4225 U1111-1204-8909, 2017-004528-31 | Ph 1 | completed | A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week |
| NCT04795531 ONWARDS 3 results posted | NN1436-4479 U1111-1247-5218, 2020-000472-37 | Ph 3 | completed | A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3) |
| NCT04597697 | NN1436-4570 | Ph 1 | completed | A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People With Liver Disease |
| NCT03723785 | NN1436-4226 2017-004529-34, U1111-1204-8972 | Ph 1 | completed | A Research Study of How a New Medicine NNC0148-0287 C (Insulin 287) Works in the Body of People With Kidney Problems |
| NCT04582435 | NN1436-4569 U1111-1244-4346, 2019-004606-10 | Ph 1 | completed | A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabetes |
| NCT03945656 | NN1436-4462 U1111-1214-2688, 2018-001993-74 | Ph 1 | completed | A Research Study of How Overdosing of a New Once Weekly Medicine NNC0148-0287 C (Insulin 287) Influences the Blood Sugar Level in People With Type 2 Diabetes |
| NCT04857398 | NN1436-4571 U1111-1244-4473 | Ph 1 | completed | A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People From China With Type 2 Diabetes |
| NCT04582448 | NN1436-4572 U1111-1244-4495, 2019-004660-21 | Ph 1 | completed | A Study Looking at How Insulin Icodec is Taken up in the Blood When Administered in Different Injection Sites in People With Type 2 Diabetes |
| NCT03922750 results posted | NN1436-4466 U1111-1219-5541, 2018-003407-18 | Ph 2 | completed | A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine |
| NCT02964104 | NN1436-4314 2016-000436-18, U1111-1178-9795 | Ph 1 | completed | A Trial Investigating the Safety, Tolerability, Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Pharmacodynamics (the Effect of the Investigated Drug on the Body) of Insulin 287 in Subjects With Type 2 Diabetes |
| NCT03951805 results posted | NN1436-4465 U1111-1219-5474, 2018-003406-11 | Ph 2 | completed | A Research Study to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine in People With Type 2 Diabetes Who Have Not Used Insulin Before |
| NCT03751657 results posted | NN1436-4383 U1111-1208-4124, 2018-000322-63 | Ph 2 | completed | A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes. |
| NCT03766854 | NN1436-4422 U1111-1211-7635 | Ph 1 | completed | A Research Study of How Different Amounts of a New Medicine NNC0148-0287 C (Insulin 287) Works on the Blood Sugar of People Who Are Japanese With Type 1 Diabetes When Given Once a Week |
| NCT02148861 | NN1436-4057 2013-001180-22, U1111-1140-5344 | Ph 1 | completed | A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AWIQLI FLEXTOUCH FDA Label Details
Indications & Usage
FDA Label (PDF)Awiqli is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Awiqli is a long-acting human insulin analog indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment