Data updated: May 26, 2026
FIASP PENFILL (insulin aspart)
Metabolic
Approved 2017-09-29
FIASP PENFILL (insulin aspart) is a rapid-acting human insulin analog. It is indicated to improve glycemic control in both adult and pediatric patients diagnosed with diabetes mellitus. This medication plays a therapeutic role in the clinical management of blood sugar levels for these patient populations.
How FIASP PENFILL Works
Insulin aspart regulates glucose metabolism by lowering blood glucose levels. It achieves this by stimulating peripheral glucose uptake in skeletal muscle and fat and by inhibiting the production of glucose in the liver. Additionally, the drug inhibits the breakdown of fats and proteins while enhancing protein synthesis.
3
Indications
--
Phase 3 Trials
8
Years on Market
Details
- Status
- Prescription
- First Approved
- 2017-09-29
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
FIASP PENFILL Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
11 FDA actions from 2017 to 2023 · 1 indication expansions
Sep 2018 SUPPL
Mfg
Sep 2018 SUPPL
Label
Jul 2018 SUPPL
Mfg
Mar 2018 SUPPL
Label
What FIASP PENFILL Treats
1 indicationsFIASP PENFILL is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
Source: FDA Label
FIASP PENFILL Competitive Set
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MoA expansion candidates
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Indication competitors
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What's emerging in FIASP PENFILL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications FIASP PENFILL treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
103 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07068295 | NN1471-5026 U1111-1283-0507, 2024-520230-29 | Ph 1 | completed | A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 2 Diabetes When Given by an Insulin Pump |
| 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 |
| 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) |
| NCT04588259 results posted | NN1218-4357 U1111-1197-8289 | Ph 3 | completed | Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes |
| 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) |
| NCT02546401 BOLUS | RB 15-027 2015-000915-42 | Ph 3 | completed | Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump |
| NCT05013229 | NN1535-4593 U1111-1260-8295, 2020-005309-18 | 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 Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3) |
| NCT04124302 | Mixed Meal Bolus | Ph 4 | completed | The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal. |
| NCT06809621 | NN1471-7712 U1111-1306-8005, 2024-513472-18 | Ph 1 | completed | A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 1 Diabetes When Given by an Insulin Pump |
| NCT02462161 SNIFF-Quick | IRB00026106 5P50AG005136-30 | Ph 1 | completed | Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart |
| NCT04538352 TRANSITION-T2D results posted | 20-853 | Ph 4 | completed | Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D |
| NCT06558708 | GZR101-T2D-202 | Ph 2 | recruiting | A Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection Once Daily (OD) and GZR33-70 Injection OD |
| NCT04012138 InSaKa | RC19_0048 | Ph 4 | completed | Insulin Dextrose Infusion vs Nebulized Salbutamol vs Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia |
| NCT03874715 GEMELLI X results posted | EFC15178 U1111-1197-7811, 136342 | Ph 3 | completed | Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine |
| NCT03660553 results posted | 20180541 | Ph 4 | terminated | Simplified Insulin Regimen for the Elderly |
| NCT04019821 | SuperBolus | Ph 4 | completed | Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal |
| NCT02408120 results posted | IRB00078695 | Ph 4 | completed | Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes |
| NCT00913497 results posted | 2009-089 | Ph 4 | completed | The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children |
| NCT03737240 results posted | IRB00104726 | Ph 3 | completed | IDegLira HIGH Trial |
| NCT03659799 | FiAsp-Exercise | Ph 4 | completed | Comparison of FiAsp and Aspart During Postprandial Exercise in Adults With Type 1 Diabetes |
| NCT03377699 EXPECT results posted | NN1250-4300 U1111-1191-3018, 2017-000048-17 | Ph 3 | completed | Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes |
| NCT03689374 SUSTAIN 11 results posted | NN9535-4386 U1111-1200-0164, 2017-003219-20 | Ph 3 | completed | A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes |
| NCT03202875 | PDY12695 2012-002355-42, U1111-1127-2950 | Ph 1 | completed | A Study to Compare Pharmacokinetics (PK) and Pharmacodynamics (PD) of SAR341402 to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus |
| NCT03436498 | PDY15083 U1111-1200-1241 | Ph 1 | completed | Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients |
| NCT03916601 | PDY15084 2017-002482-22, U1111-1197-7984 | Ph 1 | completed | Comparison of Exposure and Activity of SAR341402 Mix 70/30 to NovoLog Mix 70/30, NovoMix 30 and SAR341402 Rapid-acting Solution in Patients With Type 1 Diabetes Mellitus |
| NCT02910518 | BEQ13941 2016-001498-34, U1111-1183-8636 | Ph 1 | completed | A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus |
| NCT03211858 GEMELLI1 results posted | EFC15081 2017-000091-28, U1111-1191-5775 | Ph 3 | completed | Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine |
| NCT00591227 results posted | 07070902 | Ph 4 | completed | Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol. |
| NCT03268005 onset 9 results posted | NN1218-4113 U1111-1180-0636, 2016-000878-38 | Ph 3 | completed | Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes |
| NCT01293396 HUCKEPACK2 results posted | ENM-DA-008 2008-008486-35 | Ph 4 | completed | Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids |
| NCT03511521 results posted | STU00207079 | Ph 4 | terminated | Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia |
| NCT03430856 results posted | TREGO-DM2-03-I-01 | Ph 2, Ph 3 | completed | Comparison of Insulin Tregopil (IN-105) With Insulin Aspart in Type 2 Diabetes Mellitus Patients |
| NCT03449433 results posted | 16911 I8B-MC-ITSL, 2017-003459-47 | Ph 1 | completed | A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus |
| NCT02825251 Onset® 5 results posted | NN1218-3854 2010-024054-11, U1111-1118-2480 | Ph 3 | completed | Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes |
| NCT02906917 results posted | NN5401-4266 2015-004768-12, U1111-1175-7895 | Ph 3 | completed | A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification |
| NCT01966978 SIMPLE results posted | STU 072013-030 | Ph 4 | completed | The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study |
| NCT01513473 BEGIN™ results posted | NN1250-3561 2011-003148-39, P/44/2010 | Ph 3 | completed | A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus |
| NCT01831765 onset® 1 results posted | NN1218-3852 2010-024049-53, U1111-1118-2442 | Ph 3 | completed | Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes |
| NCT02500706 onset®8 results posted | NN1218-4131 2015-001047-36, U1111-1167-9495 | Ph 3 | completed | Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes |
| NCT01835431 results posted | NN5401-3816 2012-003566-41, U1111-1133-0958 | Ph 3 | completed | A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus |
| NCT02670915 onset®7 results posted | NN1218-4101 2014-002568-33, U1111-1158-1170 | Ph 3 | completed | Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes |
| NCT02933853 | NN1218-4265 2016-000200-28, U1111-1178-3964 | Ph 1 | completed | A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus |
| NCT03215498 | NN1218-4349 2016-004306-34, U1111-1189-1545 | Ph 1 | completed | A Research Study of How Faster-acting Insulin Aspart Moves Into, Through, and Out of the Body and How it Works in the Body When Given Through an Insulin Pump to People With Type 1 Diabetes |
| NCT01526733 results posted | Halo-117-401 | Ph 4 | completed | Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase |
| NCT01194245 results posted | HALO-117-205 | Ph 2 | completed | Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus |
| NCT02453685 results posted | BIASP-4157 2014-003708-62, U1111-1158-7280 | Ph 4 | completed | A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients |
| NCT01819129 onset® 2 results posted | NN1218-3853 2010-024051-93, U1111-1118-2509 | Ph 3 | completed | Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes |
| NCT02269735 | 2640-001 | Ph 1 | completed | A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001) |
| NCT02034513 SWITCH 1 results posted | NN1250-3995 U1111-1129-9668, 2012-001930-32 | Ph 3 | completed | A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes |
| NCT02003677 | NN1218-3891 2011-002626-46, U1111-1121-8758 | Ph 1 | completed | A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Geriatric and Younger Adult Subjects With Type 1 Diabetes |
Showing 50 of 103 trials
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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.
FIASP PENFILL FDA Label Details
Indications & Usage
FDA Label (PDF)FIASP PENFILL is indicated for the treatment of Diabetes.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.