UNLOXCYT

(Cosibelimab)

ApprovedMonoclonal antibody

Sun Pharmaceutical Industries, Inc.

UNLOXCYT is one of 95 small molecule programs targeting Kidney Transplant. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Kidney TransplantActive, not recruiting

Cutaneous Squamous Cell CarcinomaRecruiting

Pancreatic Ductal AdenocarcinomaNot yet recruiting

Kidney TransplantApproved

Active, not recruiting

Cutaneous Squamous Cell CarcinomaApproved

Recruiting

Pancreatic Ductal AdenocarcinomaPhase 1

Not yet recruiting

Competition

Competitive Landscape

121 competitors in Kidney Transplant

#DrugCompanyPhaseTrials

UNLOXCYT

Sun Pharmaceutical Industries, Inc.

Approved

4 2

Prevymis

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

3 3

Felzartamab

Biogen

Phase 3

1 4

Biological/vaccine

Vertex Pharmaceuticals

Phase 3

1 5

Envarsus XR

UUniversity of Wisconsin, Madison

Phase 3

2 6

Cytogam

JJohns Hopkins University

Phase 3

2 7

Zemplar

AbbVie

Preclinical

2 8

Cysteine Hydrochloride

Novartis

Preclinical

1 9

Sensipar

Amgen

Preclinical

1 10

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 1Not yet recruiting

Pancreatic Ductal Adenocarcinoma

NCT06981806

Q4 2032

ApprovedRecruiting

Cutaneous Squamous Cell Carcinoma

NCT07426484

Clinical

Trials by Indication[1]

Non-squamous NSCLC1 trial

Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab in First Line Metastatic Non-squamous NSCLC

Terminated·CCheckpoint Therapeutics, Inc.·Phase 3·NCT04786964·25 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

Phase I Study of Cosibelimab and Balixafortide in Metastatic Pancreatic Ductal Adenocarcinoma

Not yet recruiting·AArsen Osipov·Phase 1·NCT06981806·24 enrolled

Lymphoma1 trial

Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

Terminated·TTG Therapeutics, Inc.·Phase 1·NCT03778073·18 enrolled

Cutaneous Squamous Cell Carcinoma1 trial

A Phase IV Master Protocol of Cosibelimab in Special Populations With Advanced Cutaneous Squamous Cell Carcinoma (CosiMaster)

Recruiting·DDana-Farber Cancer Institute·Approved·NCT07426484·80 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 13, 2024

UNLOXCYT

BLA BLA761297

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Cosibelimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cosibelimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cosibelimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761297). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Sun Pharmaceutical Industries, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Approved[1]
Company: Sun Pharmaceutical Industries, Inc.

UNLOXCYT

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2032

Trials by Indication[1]

Non-squamous NSCLC1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Lymphoma1 trial

Cutaneous Squamous Cell Carcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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