Wednesday, July 8, 2026

Drug profile · INN

insulin aspart

insulin aspart (FIASP PENFILL) is a insulin receptor agonist. Associated with NovoThirteen. Route of administration: subcutaneous. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Alimentary tract and metabolism (A10) A10AB05
US status approved
Patents linked 5
Pipeline programs 19
News articles 0
Drug details — insulin aspart
US status
approved
Class
Alimentary tract and metabolism (A10)
Route
SUBCUTANEOUS
Patents
5
Programs
19
Data quality
0.84

Quick answer

insulin aspart (FIASP PENFILL) is a insulin receptor agonist. Associated with NovoThirteen. Route of administration: subcutaneous. Current US regulatory status: approved.

Key facts

INN insulin aspart
Brand FIASP PENFILL
Mechanism Insulin receptor agonist
Target Insulin receptor
Therapeutic class Alimentary tract and metabolism (A10)
Route SUBCUTANEOUS
Formulation SOLUTION
ATC code A10AB05
Originator NovoThirteen

Mechanism of action

Insulin receptor agonist

Primary target: Insulin receptor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. Faster-acting insulin aspart Phase 3 · Novo Nordisk A/S · Diabetes
  2. Insulin Degludec and Insulin Aspart Phase 3 · Sunshine Guojian Pharmaceutical · Diabetes
  3. Insulin degludec/insulin aspart Phase 3 · Novo Nordisk A/S · Diabetes
  4. biphasic insulin aspart Phase 3 · Novo Nordisk A/S · Diabetes
  5. EG-70 (phase 1) Phase 2 · Shanghai Antengene Corporation · Superficial Bladder Cancer
  6. Insulin Phase 2 · United Therapeutics Europe · Acute Stroke
  7. Insulin Phase 2 · United Therapeutics Europe · Multiple Sclerosis, Relapsing-Remitting
  8. MLS-101 (Part I) Phase 2 · Mineralys Therapeutics · Hypertension, Renal

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. alogliptin Alimentary tract and metabolism (A10)
  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)
  1. EP 4732903

    COKRISTALLE VON PITOLISTANTHYDROCHLORID

    Expires Tue Apr 24 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12325732

    Pro-insulin aspart structure and method for preparing insulin aspart

    Expires Mon Jun 05 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 2020024256

    TETRAHYDRATE OF H3 LIGAND, ITS PROCESS OF PREPARATION AND PHARMACEUTICAL COMPOSITIONS COMPRISING THE SAME

    Expires Wed Jan 18 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. EP 3378477

    NEUE THERAPEUTISCHE VERWENDUNGEN VON H3-LIGANDEN

    Expires Tue Sep 21 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. EP 2014653

    Neue Dicarbonsäurederivate als S1P1 Rezeptor Agonisten

    Expires Tue Jan 09 2029 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is insulin aspart?

insulin aspart (FIASP PENFILL) is a insulin receptor agonist. Associated with NovoThirteen. Route of administration: subcutaneous. Current US regulatory status: approved.

What is the brand name for insulin aspart?

FIASP PENFILL is a marketed brand name for insulin aspart. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of insulin aspart?

insulin aspart has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.