Wednesday, July 8, 2026

Drug profile · INN

omalizumab

omalizumab (OMLYCLO) is a ig epsilon chain c region inhibitor. Associated with Novartis Pharmaceuticals. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved Respiratory system (R03) R03DX05
US status approved
Patents linked 0
Pipeline programs 7
News articles 0
Drug details — omalizumab
US status
approved
Class
Respiratory system (R03)
Route
Patents
0
Programs
7
Data quality
0.83

Quick answer

omalizumab (OMLYCLO) is a ig epsilon chain c region inhibitor. Associated with Novartis Pharmaceuticals. Current US regulatory status: approved.

Key facts

INN omalizumab
Brand OMLYCLO
Mechanism Ig epsilon chain C region inhibitor
Target Immunoglobulin heavy constant epsilon
Therapeutic class Respiratory system (R03)
Formulation VIAL
ATC code R03DX05

Mechanism of action

Ig epsilon chain C region inhibitor

Primary target: Immunoglobulin heavy constant epsilon

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved

Pipeline programs

  1. BP11-301 Phase 3 · CuraTeQ Biologics s.r.o · Chronic Urticaria
  2. CLOU064A2304 Phase 3 · Novartis India · Chronic Spontaneous Urticaria
  3. Omalizumab (Xolair) Phase 3 · BRIGHT MINDS BIOSCIENCES · Chronic Urticaria
  4. LT-02-19 Phase 1 · Tillomed Laboratories · Chronic spontaneous urticaria, Allergic asthma, Chronic rhin
  5. 19-659 Approved · Disc Medicine · Carotid artery stenosis
  6. Xolair Approved · United Therapeutics Europe · Atopic Eczema
  7. Xolair 75 mg solution for injection in pre-filled syringe Approved · PARItec · Well controlled severe allergic 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 omalizumab?

omalizumab (OMLYCLO) is a ig epsilon chain c region inhibitor. Associated with Novartis Pharmaceuticals. Current US regulatory status: approved.

What is the brand name for omalizumab?

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

What is the US approval status of omalizumab?

omalizumab 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.