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FIASP

(Insulin aspart)

Phase 3

FIASP is one of 27 biologic programs targeting Gestational Diabetes. It is currently in Phase 3.

2

Indications

5

Total Trials

4

Active Trials

26

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Gestational DiabetesRecruiting

Diabetes Mellitus, Type 1Active, not recruiting

Gestational DiabetesPhase 1

Recruiting

Diabetes Mellitus, Type 1Phase 3

Active, not recruiting

Competition

Competitive Landscape

24 competitors in Gestational Diabetes

#DrugCompanyPhaseTrials

Glucophage

Diabeta

Victoza

Actigall

Calciferol

Jazz Pharmaceuticals

Byetta

Ozempic

Insulin 320

Ursodeoxycholic Acid

Daewoong Pharmaceutical Co. LTD.

FIASP

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Diabetes Mellitus, Type 1

NCT07076199

Q2 2027

Phase 1Recruiting

Gestational Diabetes

NCT06547619

Phase 1Recruiting

Gestational Diabetes

NCT05946785

Q2 2028

Phase 1Active, not recruiting

Gestational Diabetes

NCT05946798

Clinical

Trials by Indication[1]

Gestational Diabetes3 trials

Role of Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes

Recruiting·AAnna Stanhewicz, PhD·Phase 1·NCT05946785·28 enrolled

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

Recruiting·AAnna Stanhewicz, PhD·Phase 1·NCT06547619·40 enrolled

Role of NADPH Oxidase in Microvascular Dysfunction Following GDM

Active, not recruiting·AAnna Stanhewicz, PhD·Phase 1·NCT05946798·40 enrolled

Diabetes Mellitus, Type 12 trials

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 1 Diabetes

Completed· Novo Nordisk logo

Novo Nordisk·Phase 1·NCT06809621·43 enrolled

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

Active, not recruiting· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT07076199·877 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 1, 2001

INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30

BLA BLA021172

Sep 29, 2017

FIASP

BLA BLA208751

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Insulin aspart. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Insulin aspart compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Insulin aspart. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA208751). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Novo Nordisk company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Highest Phase: Phase 3[1]
Company: Novo Nordisk

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