Tenalisib

Generic Name: Tenalisib

Drug Type: Small Molecule

Chemical Formula: C_₂₃H_₁₈FN_₅O_₂

CAS Number: 1639417-53-0

Unique Ingredient Identifier: 2261HH611H

Background: Tenalisib is under investigation in clinical trial NCT03711604 (Compassionate Use Study of Tenalisib (RP6530)).

Clinical Trials

Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)

Phase 2

Recruiting

Conditions: Triple Negative Breast Cancer (TNBC)

Interventions: Drug: Tenalisib

First Posted Date: 2024-01-03

Last Posted Date: 2025-03-11

Lead Sponsor: Rhizen Pharmaceuticals SA

Target Recruit Count: 40

Registration Number: NCT06189209

Locations: 🇮🇳
HCG City Cancer Center, Vijayawada, Andhra Pradesh, India
🇮🇳
Sahyadri Super Speciality Hospital, Pune, Maharashtra, India
🇮🇳
Narayana Hrudayala Majumdar Shaw Hospital, Bangalore, Karnataka, India

and more 4 locations

Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL

Phase 2

Withdrawn

Conditions: Peripheral T Cell Lymphoma

Interventions: Drug: Tenalisib

First Posted Date: 2022-02-15

Last Posted Date: 2022-10-17

Lead Sponsor: Rhizen Pharmaceuticals SA

Registration Number: NCT05239910

Locations: 🇺🇸
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Efficacy and Safety of Tenalisib (RP6530), in Patients With Locally Advanced or Metastatic Breast Cancer

Phase 2

Completed

Conditions: Locally Advanced Breast Cancer
Metastatic Breast Cancer

Interventions: Drug: Tenalisib 1200mg
Drug: Tenalisib 800mg

First Posted Date: 2021-08-26

Last Posted Date: 2024-08-13

Lead Sponsor: Rhizen Pharmaceuticals SA

Target Recruit Count: 40

Registration Number: NCT05021900

Locations: 🇬🇪
High Technology Hospital Medcenter, Batumi, Georgia
🇬🇪
LLC Caucasus Medical Center, Tbilisi, Georgia
🇬🇪
Simon Khechinashvili University Hospital, Tbilisi, Georgia

Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

Phase 2

Completed

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Interventions: Drug: Tenalisib

First Posted Date: 2019-12-18

Last Posted Date: 2024-08-13

Lead Sponsor: Rhizen Pharmaceuticals SA

Target Recruit Count: 21

Registration Number: NCT04204057

Locations: 🇵🇱
Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J., Chorzow, Poland
🇧🇬
University Multiprofile Hospital for Active Treatment "Sv Ivan Rilski" Ltd, Sofia, Bulgaria
🇧🇬
University Multiprofile Hospital for Active Treatment "Dr Georgi Stranski" Ltd.,, Pleven, Bulgaria

and more 3 locations

Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma

Phase 1

Completed

Conditions: T Cell Lymphoma

Interventions: Drug: Tenalisib
Drug: Romidepsin

First Posted Date: 2018-12-10

Last Posted Date: 2022-10-28

Lead Sponsor: Rhizen Pharmaceuticals SA

Target Recruit Count: 33

Registration Number: NCT03770000

Locations: 🇺🇸
John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
University of Colorado Cancer Center, Aurora, Colorado, United States
🇺🇸
Rush University Cancer Center, Chicago, Illinois, United States

and more 12 locations

Compassionate Use Study of Tenalisib (RP6530)

Phase 1

Completed

Conditions: Hematological Malignancies

Interventions: Drug: Tenalisib

First Posted Date: 2018-10-18

Last Posted Date: 2024-05-08

Lead Sponsor: Rhizen Pharmaceuticals SA

Target Recruit Count: 17

Registration Number: NCT03711604

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, United States
🇬🇪
Ltd. M.Zodelava Hematology Centre, Tbilisi, Georgia
🇺🇸
Division of Hematology, University of Colorado,, Denver, Colorado, United States

and more 4 locations

Safety and Efficacy Study of Tenalisib (RP6530) in Combination With Pembrolizumab in Relapsed or Refractory cHL

Phase 1

Terminated

Conditions: Classical Hodgkin Lymphoma

Interventions: Drug: Tenalisib
Biological: Pembrolizumab

First Posted Date: 2018-03-20

Last Posted Date: 2019-12-27

Lead Sponsor: Rhizen Pharmaceuticals SA

Target Recruit Count: 2

Registration Number: NCT03471351

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States
🇺🇸
University of Washington, Seattle, Washington, United States
🇺🇸
Rhizen Pharmaceuticals investigational trial site; Karmanos Cancer Institute,, Detroit, Michigan, United States

To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: RP6530

First Posted Date: 2016-02-24

Last Posted Date: 2017-11-28

Lead Sponsor: Rhizen Pharmaceuticals SA

Target Recruit Count: 18

Registration Number: NCT02690727

Locations: 🇨🇦
Algorithme Pharma Inc, Quebec, Canada

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma

Phase 1

Completed

Conditions: Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell, Cutaneous

Interventions: Drug: RP6530

First Posted Date: 2015-10-05

Last Posted Date: 2020-01-13

Lead Sponsor: Rhizen Pharmaceuticals SA

Target Recruit Count: 58

Registration Number: NCT02567656

Locations: 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
Chao Family Comprehensive Cancer Center University of California Irvine, Orange, California, United States
🇺🇸
University of Colorado Cancer Center, Aurora, Colorado, United States

and more 5 locations

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies

Phase 1

Completed

Conditions: Lymphoma, B-Cell
T-Cell Lymphoma

Interventions: Drug: RP6530

First Posted Date: 2013-12-23

Last Posted Date: 2016-06-24

Lead Sponsor: Rhizen Pharmaceuticals SA

Target Recruit Count: 35

Registration Number: NCT02017613

Locations: 🇫🇷
Rhizen Trial Site, Paris, France
🇮🇹
Rhizen Trial Site 1, Milano, Italy
🇮🇹
Rhizen Trial Site 2, Milano, Italy

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy