EU-approved Xolair

Phase 3Biologic

KKashiv BioSciences, LLC

EU-approved Xolair is one of 98 biologic programs targeting Lung Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Lung CancerActive, not recruiting

PsoriasisActive, not recruiting

Chronic Spontaneous UrticariaActive, not recruiting

Lung CancerPhase 3

Active, not recruiting

PsoriasisPhase 3

Active, not recruiting

Chronic Spontaneous UrticariaPhase 3

Active, not recruiting

Competition

Competitive Landscape

686 competitors in Lung Cancer

#DrugCompanyPhaseTrials

EU-approved Xolair

KKashiv BioSciences, LLC

Phase 3

10 2

Tecentriq

Roche

Preclinical

9 3

Vizimpro

Pfizer

Preclinical

3 4

Talzenna

Pfizer

Preclinical

2 5

Folvite

Xylocaine

2 7

Immunotherapy

Bristol-Myers Squibb

Preclinical

5 8

Paclitaxel and Carboplatin

Bristol-Myers Squibb

Preclinical

2 9

Rilotumumab

Amgen

Preclinical

2 10

Acupan

YYonsei University

Preclinical

—

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Psoriasis

NCT06630559

Q3 2028

Phase 3Active, not recruiting

Non-Squamous Non-Small Cell Lung Cancer

NCT06939595

Clinical

Trials by Indication[1]

Immunogenicity3 trials

To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab)

Active, not recruiting·CCelltrion·Phase 1·NCT06687928·200 enrolled

To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects

Completed·CCelltrion·Phase 1·NCT07054970·172 enrolled

To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects

Completed·KKashiv BioSciences, LLC·Phase 1·NCT05413161·306 enrolled

Psoriasis2 trials

Assessment on Efficacy and Safety of BAT2306 and Cosentyx® in Plaque Psoriasis Patients

Completed·BBio-Thera Solutions·Phase 3·NCT05377944·502 enrolled

A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients With Moderate to Severe Psoriasis

Active, not recruiting·CCelltrion·Phase 3·NCT06630559·153 enrolled

MPA1 trial

Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy Subjects

Completed·CCelltrion·Phase 1·NCT04428814·271 enrolled

Chronic Spontaneous Urticaria1 trial

To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria

Completed·CCelltrion·Phase 3·NCT04426890·634 enrolled

Tics1 trial

A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects

Completed·CCelltrion·Phase 1·NCT04512872·30 enrolled

2 more indications

Omalizumab1 trial

To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects

Completed·CCelltrion·Phase 1·NCT04018313·176 enrolled

Non-Squamous Non-Small Cell Lung Cancer1 trial

A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P51 and Keytruda in Combination With Platinum-Pemetrexed Chemotherapy in Patients With Previously Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer

Active, not recruiting·CCelltrion·Phase 3·NCT06939595·225 enrolled

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for EU-approved Xolair. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — EU-approved Xolair compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for EU-approved Xolair. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Kashiv BioSciences, LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 3[1]
Company: KKashiv BioSciences, LLC

EU-approved Xolair

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2028

Trials by Indication[1]

Immunogenicity3 trials

Psoriasis2 trials

MPA1 trial

Chronic Spontaneous Urticaria1 trial

Tics1 trial

Omalizumab1 trial

Non-Squamous Non-Small Cell Lung Cancer1 trial

References

Drug Info

Quick Facts

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