Drug

Insulin Aspart

Approved · EMA

ClassInsulin receptor agonistEmerging researchLate-stage developmentRising momentum

Also known as Aspart, Aspart Insulin, B28-Aspart-Insulin, Fiasp+13 more

Aspart, Aspart Insulin, B28-Aspart-Insulin, Fiasp, Insulin X14, Insulin aspart soluble, Kirsty, Merilog, NovoLOG, NovoLog Mix, insulin aspart, human, Insulina asparta, INSULIN,ASPART,HUMAN/rDNA, Insulin Aspart (Recombinant), Insulin aspart protamine recombinant, Insulin aspart recombinant, Insulin, aspart, human.

RxNorm51428 ChEMBLCHEMBL1201496 ATCA10AD05 ATCA10AB05UNIID933668QVX

Research papers

Active clinical trials

Insulin receptor

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

Clinical trial2026-06-29Results expected Q1 2027 · ClinicalTrials.gov

Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers: A Single-Center Randomized, Double-Blinded, Two-Treatment, Two-Period, Two-Sequence, Crossover, Hyperinsulinemia-Euglycemic Clamp Study

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM

Clinical trial2026-05-01Primary completion · ClinicalTrials.gov

Approval: Dazparda (EMA)

Regulatory2026-04-27EMA

A Study Investigating the Pharmacokinetic and Pharmacodynamic Properties and Safety and Tolerability of NNC0471-0119 H When Administered as Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 2 Diabetes

Clinical trial2026-03-10Completed · ClinicalTrials.gov

Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial.

Research2024-02-29Journal of diabetes science and technology

Postprandial Glucose Excursions with Ultra-Rapid Insulin Analogs in Hybrid Closed-Loop Therapy for Adults with Type 1 Diabetes.

Research2024-02-27Diabetes technology & therapeutics

Market withdrawal: Truvelog Mix 30 (EMA)

Regulatory2024-01-25EMA

Pharmacokinetic similarity of switching SAR341402 insulin aspart biosimilar and NovoLog insulin aspart versus continuous use of NovoLog in adults with type 1 diabetes: The GEMELLI X trial.

Research2023-10-25Diabetes, obesity & metabolism

Approval: Kirsty (previously Kixelle) (EMA)

Regulatory2021-02-05EMA

Approval: Insulin aspart Sanofi (EMA)

Regulatory2020-06-25EMA

A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5).

Research2019-01-13Diabetes, obesity & metabolism

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Insulin Aspart

Aliases & brands

AspartAspart InsulinB28-Aspart-InsulinFiaspInsulin X14Insulin aspart solubleKirstyMerilogNovoLOGNovoLog Mixinsulin aspart, humanInsulina aspartaINSULIN,ASPART,HUMAN/rDNAInsulin Aspart (Recombinant)Insulin aspart protamine recombinantInsulin aspart recombinantInsulin, aspart, human

RxNorm CUI

51428

ChEMBL ID

CHEMBL1201496

ATC codes

A10AD05A10AB05

UNII

D933668QVX

Primary mechanism

Insulin receptor agonist

Regulatory jurisdictions

ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Insulin receptor

INSR · P06213

AGONISTInsulin receptor agonist

Regulatory timeline

6 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

1999-09-07

Latest approval

2026-04-27

Authorities

EMA

Total events

emaEuropean Medicines Agency· 6 events

2026-04-27Approval

Approval: Dazparda (EMA)

Indication: Dazparda is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Evidence ↗

2024-01-25Market withdrawalMarket

Market withdrawal: Truvelog Mix 30 (EMA)

Indication: Truvelog Mix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.

Evidence ↗

2021-02-05Approval

Approval: Kirsty (previously Kixelle) (EMA)

Indication: Kirsty is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

181 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

181

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

127

Late-stage (III+)

150

Completed

Discontinued

PHASE DISTRIBUTIONn = 181

Early Phase 14Phase 140Phase 1 / 22Phase 28Phase 2 / 33Phase 358Phase 455Phase N / A11

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

InSaKa Trial: Insulin Dextrose Infusion Versus Nebulized Salbutamol Versus Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia: a Randomized Clinical Trial

CompletedPH IVNantes University Hospitaln=4192025

The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal in Children With Type 1 Diabetes Mellitus- Randomized Study.

CompletedPH IVMedical University of Warsawn=762024

The Effect of Short-term Insulin Intensive Therapy Based on the Application of Insulin Pump and Real-time Dynamic Glucose Monitoring Technology on Reversing the Newly Diagnosed Type 2 Diabetes

Unknown statusPH IVSun Yat-sen Universityn=2102024

Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With Type-2 Diabetes Mellitus (TRANSITION-T2D) A Prospective Randomized Controlled Trial

CompletedPH IVThe Cleveland Clinicn=602023

Fast-Acting Insulin Aspart and Insulin Pump Settings: THE FAST PUMP SETTING STUDY

Unknown statusPH IVKirsten Nørgaardn=402022

Recent completions

Trials that read out recently, adding to the completed evidence base.

CompletedPH INovo Nordisk A/Sn=652026

InSaKa Trial: Insulin Dextrose Infusion Versus Nebulized Salbutamol Versus Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia: a Randomized Clinical Trial

CompletedPH IVNantes University Hospitaln=4192025

A Multicenter, Randomized, Open, Parallel-controlled Clinical Trial to Compare the Efficacy and Safety of IDegAsp BID and IDegAsp QD+2IAsp in Patients With Type 2 Diabetes Mellitus

CompletedN/ABeijing Hospitaln=2182025

The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal in Children With Type 1 Diabetes Mellitus- Randomized Study.

CompletedPH IVMedical University of Warsawn=762024

A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3

CompletedPH IIINovo Nordisk A/Sn=6792023

Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With Type-2 Diabetes Mellitus (TRANSITION-T2D) A Prospective Randomized Controlled Trial

CompletedPH IVThe Cleveland Clinicn=602023

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20182025

Most influential

A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5).

Diabetes, obesity & metabolism · 2019 · 54 cites

Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes.

Journal of diabetes science and technology · 2018 · 38 cites

Postprandial Glucose Excursions with Ultra-Rapid Insulin Analogs in Hybrid Closed-Loop Therapy for Adults with Type 1 Diabetes.

Diabetes technology & therapeutics · 2024 · 9 cites

Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial.

Journal of diabetes science and technology · 2025 · 3 cites

Pharmacokinetic similarity of switching SAR341402 insulin aspart biosimilar and NovoLog insulin aspart versus continuous use of NovoLog in adults with type 1 diabetes: The GEMELLI X trial.

Diabetes, obesity & metabolism · 2024 · 2 cites

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Insulin Lispro

Acts on the same molecular target as Insulin Aspart, with an overlapping disease area.

Shared target1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.