Wednesday, July 8, 2026

Drug profile · INN

mepolizumab

mepolizumab (NUCALA) is a interleukin-5 inhibitor. Associated with GlaxoSmithKline. Route of administration: subcutaneous. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved Respiratory system (R03) R03DX09
US status approved
Patents linked 0
Pipeline programs 9
News articles 0
Drug details — mepolizumab
US status
approved
Class
Respiratory system (R03)
Route
SUBCUTANEOUS
Patents
0
Programs
9
Data quality
0.84

Quick answer

mepolizumab (NUCALA) is a interleukin-5 inhibitor. Associated with GlaxoSmithKline. Route of administration: subcutaneous. Current US regulatory status: approved.

Key facts

INN mepolizumab
Brand NUCALA
Mechanism Interleukin-5 inhibitor
Target Interleukin-5
Therapeutic class Respiratory system (R03)
Route SUBCUTANEOUS
Formulation INJECTABLE
ATC code R03DX09

Mechanism of action

Interleukin-5 inhibitor

Primary target: Interleukin-5

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved

Pipeline programs

  1. 104317 Phase 3 · GSK Glaxo Smith · Hypereosinophilic Syndrome
  2. 206785 Phase 3 · GSK Glaxo Smith · Severe asthma with an eosinophilic phenotype
  3. 217102 Phase 3 · GSK Glaxo Smith · Relapsing or refractory Eosinophilic Granulomatosis with Pol
  4. D20180135 Phase 3 · PARItec · Eosinophilic granulomatosis with polyangiitis (EGPA), former
  5. D3253C00001 Phase 3 · AstraZeneca · Eosinophilic Granulomatosis with Polyangiitis (EGPA)
  6. MEPOLIZUMAB Phase 3 · GSK Glaxo Smith · Hypereosinophilic syndrome (HES)
  7. Mepolizumab Phase 1 · BRIGHT MINDS BIOSCIENCES · Healthy Subjects
  8. 219871 Approved · GSK Glaxo Smith · severe asthma

Related & competitor drugs

  1. desloratadine Respiratory system (R01)
  2. deutivacaftor / tezacaftor / vanzacaftor Respiratory system (R07)
  3. ivacaftor Respiratory system (R07)
  4. lumacaftor Respiratory system (R07)
  5. mannitol Respiratory system (R05)
  6. reslizumab Respiratory system (R03)

Frequently asked questions

What is mepolizumab?

mepolizumab (NUCALA) is a interleukin-5 inhibitor. Associated with GlaxoSmithKline. Route of administration: subcutaneous. Current US regulatory status: approved.

What is the brand name for mepolizumab?

NUCALA is a marketed brand name for mepolizumab. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of mepolizumab?

mepolizumab 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.