Bimiralisib

Overview

Bimiralisib is under investigation in clinical trial NCT02723877 (PQR309 and Eribulin in Metastatic HER2 Negative and Triple-negative Breast Cancer (PIQHASSO)).

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis	2024/03/20	NCT06319794	Phase 2	Recruiting	TORQUR
Single-arm Study With Bimiralisib in Patients With HNSCC Harboring NOTCH1 Loss of Function Mutations	2018/11/14	NCT03740100	Phase 2	Terminated	M.D. Anderson Cancer Center
Phase 2 Study With PQR309 in Relapsed or Refractory Lymphoma Patients	2017/04/25	NCT03127020	Phase 2	Completed	PIQUR Therapeutics AG
PQR309 in Phase 2 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma	2017/04/19	NCT03120000	Phase 2	Withdrawn	PIQUR Therapeutics AG
Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamic Effects of PQR309 in Glioblastoma Patients	2016/08/01	NCT02850744	Phase 2	Terminated	PIQUR Therapeutics AG
PQR309 and Eribulin in Metastatic HER2 Negative and Triple-negative Breast Cancer (PIQHASSO)	2016/03/31	NCT02723877	Phase 1	Completed	PIQUR Therapeutics AG
PQR309 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma	2016/02/01	NCT02669511	Phase 2	Completed	PIQUR Therapeutics AG
Study of Oral PQR309 in Patients With Advanced Solid Tumors	2015/06/29	NCT02483858	Phase 1	Completed	PIQUR Therapeutics AG
Open-Label, Non Randomized Phase 2 Study With Safety Run-In	2014/09/25	NCT02249429	Phase 2	Completed	PIQUR Therapeutics AG
A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PQR309	2013/09/12	NCT01940133	Phase 1	Completed	PIQUR Therapeutics AG

FDA Drug Approvals

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

EMA Drug Approvals

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

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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

PPB Drug Approvals

Approved Product	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.

Related News

Bimiralisib Gel Shows Promising Results in Phase 2 Trial for Actinic Keratosis

4 months ago

Torqur AG's interim Phase 2 results reveal 60% of patients experienced complete or partial clearance of actinic keratosis lesions, with the 4-week treatment group showing stronger response (70%) than the 2-week group (50%).

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