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Umbralisib

Generic Name
Umbralisib
Drug Type
Small Molecule
Chemical Formula
C31H24F3N5O3
CAS Number
1532533-67-7
Unique Ingredient Identifier
38073MQB2A

Overview

Marginal zone lymphoma is a rare, slowly progressing type of non-Hodgkin lymphoma initially treated with rituximab (an anti-CD20 drug), either alone or in combination with chemotherapy. Unfortunately, many patients experience a relapse or develop resistance to these drugs. Treatment options then become limited, and alternate treatments for the lymphoma are required to control disease progression. Follicular lymphoma is also treated with rituximab and other chemotherapeutic agents, but may show similar progression. On February 5, 2021, the Food and Drug Administration granted accelerated approval to umbralisib, a kinase inhibitor for PI3K-delta and casein kinase CK1-epsilon, based on promising results from clinical trials. It was marketed as Ukoniq by TG Therapeutics and has been approved for the treatment of relapsing and refractory marginal cell lymphoma and follicular lymphoma in adults. Umbralisib inhibits casein kinase, a primary regulator of protein translation, kinase-1ε, distinguishing it from other lymphoma treatments. While it initially offered a promising therapy for patients experiencing relapsing or refractory disease, umbralisib was withdrawn from the market due to safety concerns as the drug was associated with a possible increased risk of death outweighing the benefits.

Indication

Umbralisib does not have any approved therapeutic indications.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2021/12/09
Phase 1
Withdrawn
City of Hope Medical Center
2021/03/05
Phase 2
Active, not recruiting
City of Hope Medical Center
2020/12/31
Phase 1
Terminated
2020/11/19
Phase 1
Withdrawn
Yazeed Sawalha
2020/11/12
Phase 2
Active, not recruiting
Jennifer R. Brown, MD, PhD
2020/08/11
Phase 2
Completed
2019/11/15
Phase 2
Terminated
2019/11/04
Phase 2
Terminated
2019/07/11
Phase 2
Terminated
2019/04/18
Phase 2
Terminated

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Number
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Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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