OMLYCLO
GrowthmAbBLAINJECTIONINJECTABLE
Approved
Mar 2025
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
OMLYCLO by Celltrion is asthma, chronic rhinosinusitis with nasal polyps, and ige-mediated food allergy omalizumab products inhibit the binding of ige to the high-affinity ige receptor (fcεri) on the surface of mast cells, basophils, and dendritic cells, resulting in fcεri down-regulation on these cells. Approved for allergic reactions (type i), including anaphylaxis, more foods in adult and 4 more indications. First approved in 2025.
Drug data last refreshed 6h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OMLYCLO is a monoclonal antibody (mAb) therapeutic approved by the FDA on March 7, 2025, developed by Celltrion. The mechanism of action and specific indication are currently undisclosed. This product represents Celltrion's expansion into the biologic therapeutics space via BLA approval.
Growth
Early-stage mAb in growth phase with moderate competitive pressure (30/100); small or newly established commercial team expected to scale rapidly.
Mechanism of Action
Asthma, Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy Omalizumab products inhibit the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and dendritic cells, resulting in FcεRI down-regulation on these cells. In allergic…
Indications (7)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.