Insulin aspart clinical trials
Insulin aspart is named as an intervention in 3 current clinical trials in our USA, Germany, Poland, Canada, Australia, China, Japan and France registers. 2 are recruiting patients now. The most common phase is Not applicable. The sponsor with the most trials is Novo Nordisk A/S (1). The most-studied condition is Diabetes Mellitus, Type 1.
Where Insulin aspart is approved
All regulators →Of the three regulators tracked here, the first to approve Insulin aspart was the EU, on 7 Sep 1999. It is approved in 3 of the 3 regulators tracked here.
- 3 FDA-approved biosimilars, 2 interchangeable: Garzulys, Kirsty, Merilog
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Insulin aspart
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Insulin aspart works
All drug targets →- Insulin receptor agonist AgonistTarget: INSR insulin receptorChEMBL only
- Burkitt lymphomaPhase 3
- Acute lymphoblastic leukemiaPhase 3
- Cirrhosis of liverPhase 3
- Cystic fibrosis-related diabetesPhase 3
- Gestational diabetesPhase 3
- Lymphoblastic lymphomaPhase 3
- Type 1 diabetes mellitusPhase 3
- Type 2 diabetes mellitusPhase 3
- HypoglycemiaPhase 2/3
- Mental deteriorationPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201496, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Insulin aspart
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 17 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Fiasp, NovoMix, NovoRapid, Dazparda (biosimilar), Insulin aspart Sanofi (biosimilar), Kirsty (previously Kixelle) (biosimilar)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Insulin aspart
- ChEMBL
- CHEMBL1201496
- PubChem CID
- 168324416
- CAS number
- 116094-23-6
- Wikidata
- Q2754775
- Wikipedia
- Insulin aspart
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Insulin aspart
3 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients
NCT03987308 · ClinicalTrials.gov ↗ · Type 2 Diabetic Patients, T2DM (Type 2 Diabetes Mellitus), T2DM
|
Not applicable | Recruiting | Beijing Hospital | China, Japan |
|
Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes
NCT05221359 · ClinicalTrials.gov ↗ · Type 1 Diabetes, Type 1 Diabetes Mellitus With Hypoglycemia
|
Not applicable | Recruiting | Defymed | France |
|
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
NCT07076199 · Diabetes Mellitus, Type 1
|
Phase 3 | Active, closed | Novo Nordisk A/S | USA, Germany, Poland, Canada, Australia |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Insulin aspart across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
17 single-substance products containing Insulin aspart on the HPRA medicines list.
- Dazparda 100 units/ml solution for injection in pre-filled penGan & Lee Pharmaceuticals Europe GmbH · EU/1/26/2029/001-002
- Fiasp 100 units/mL FlexTouch solution for injection in pre-filled penNovo Nordisk A/S · EU/1/16/1160/001-006
- Fiasp 100 units/mL solution for injection in vialNovo Nordisk A/S · EU/1/16/1160/007-009
- Insulin aspart SanofiSanofi Winthrop Industrie · EU/1/20/1447/001-005
- Insulin aspart SanofiSanofi Winthrop Industrie · EU/1/20/1447/001-007
Supply shortages
- Fiasp PumpCart (insulin aspart)EU (EMA) · Shortage ongoing · first published 12 May 2025
- NovoRapid PumpCart (insulin aspart)EU (EMA) · Shortage ongoing · first published 12 May 2025
- Kirsty 100 Einheiten/ml Injektionslösung im FertigpenGermany (BfArM) · Other reason · 31 May 2025 to 31 Dec 2026
- Kirsty 100 Einheiten/ml Injektionslösung im FertigpenGermany (BfArM) · Other reason · 31 May 2025 to 31 Dec 2026
Recent approvals
- DazpardaEMA · 27 Apr 2026 · biosimilar · Sandoz GmbH
Conditions studied with Insulin aspart
6 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Novo Nordisk A/S | 1 |
| Beijing Hospital | 1 |
| Defymed | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Insulin aspart trials
How many clinical trials are testing Insulin aspart?
3 current trials in our USA, Germany, Poland, Canada, Australia, China, Japan and France registers name Insulin aspart as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Insulin aspart trials recruiting patients?
Yes. 2 of the 3 trials are recruiting: 1 with sites in China, 1 with sites in Japan and 1 with sites in France. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Insulin aspart clinical trials?
Novo Nordisk A/S (1), Beijing Hospital (1) and Defymed (1). The number in brackets is how many trials each organisation leads.
Is Insulin aspart licensed in Ireland?
Yes. The HPRA medicines list includes 17 single-substance products containing Insulin aspart, for example Dazparda 100 units/ml solution for injection in pre-filled pen (Gan & Lee Pharmaceuticals Europe GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Insulin aspart shortage?
The registers we track list 4 entries for Insulin aspart: Fiasp PumpCart (insulin aspart) (EU: shortage ongoing); NovoRapid PumpCart (insulin aspart) (EU: shortage ongoing); 2 German notices. Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Insulin aspart works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Insulin aspart works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Insulin aspart (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.