Ozmosi | Dovitinib Drug Profile
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Dovitinib

Alternative Names: dovitinib, chir-258, tki258, tk1258, tk-1258, tk 1258
Clinical Status: Inactive
Latest Update: 2025-05-09
Latest Update Note: News Article

Product Description

Dovitinib is a pan-tyrosine kinase inhibitor targeting fibroblast growth factor receptor (FGFR), vascular endothelial growth factor receptor (VEGFR) and other receptor tyrosine kinases (RTKs). Allarity exclusively in-licensed it (globally) from Novartis, who had completed a Phase 3 study in renal cell carcinoma (RCC) in addition to several promising Phase 2 studies in breast, liver and endometrial cancer and GIST. (Sourced from: https://allarity.com/pipeline/dovitinib/)

Mechanisms of Action: RTK Inhibitor, FGFR Inhibitor, VEGF Inhibitor, KITl Inhibitor

Novel Mechanism: Yes

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additional Commercial Interests: None

Clinical Description

Countries in Clinic:

Active Clinical Trial Count:

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Renal Cell Carcinoma|Oncology Solid Tumor Unspecified

Phase 2: Glucagonoma|Gastrinoma|Islet Cell Adenoma|Pancreatic Cancer|Breast Cancer|Renal Cell Carcinoma|Non-Small-Cell Lung Cancer|Multiple Myeloma|Colorectal Cancer|Gastrointestinal Cancer|Neuroendocrine Carcinoma|Somatostatinoma|Insulinoma|Neuroendocrine Tumors|Melanoma|Gastrointestinal Stromal Tumors|Head and Neck Cancer|Thyroid Cancer|Adenoid Cystic Carcinoma|Islet Cell Carcinoma|Ovarian Cancer|Hepatocellular Carcinoma|Acute Myeloid Leukemia|Prostate Cancer|Inflammatory Breast Cancer|Mesothelioma|Adrenocortical Carcinoma|Endometrial Cancer|von Hippel-Lindau Disease|Transitional Cell Carcinoma|Gliosarcoma|Stomach Diseases|Salivary Gland Cancer|Scirrhous Adenocarcinoma|Pheochromocytoma|Paraganglioma|Glioblastoma|Brain Cancer|Linitis Plastica|Bladder Cancer|Oncology Unspecified|Kidney Cancer|Small Cell Lung Cancer|Oncology Solid Tumor Unspecified|Male Breast Cancer

Phase 1: Breast Cancer|Kidney Cancer|Renal Cell Carcinoma|Multiple Myeloma|Gastrointestinal Stromal Tumors|Oncology Solid Tumor Unspecified|Non-Small-Cell Lung Cancer|Thrombocytopenia|Pancreatic Cancer|Diarrhea|Adenocarcinoma|Glioblastoma|Acute Myeloid Leukemia|Bladder Cancer|Neutropenia

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT05571969

AL-2003

P1

Suspended

Neutropenia|Thrombocytopenia|Diarrhea

2024-10-01

4%

2025-02-05

Primary Endpoints

ACTRN12620000921987p

OPTIMISE-C19

N/A

Not yet recruiting

COVID-19

2020-11-25

NCT00831792

NCI-2011-01106

P2

Completed

Prostate Cancer

2017-06-12

2019-03-18

Treatments

NCT01994590

NCI-2014-00887

P2

Terminated

Prostate Cancer

2017-06-05

2019-03-20

Treatments

NCT01732107

GU12-157

P2

Terminated

Transitional Cell Carcinoma|Bladder Cancer

2017-03-06

2019-03-22

JapicCTI-142557

JapicCTI-142557

N/A

Completed

Oncology Solid Tumor Unspecified

2017-03-01

NCT02116803

CTKI258A2X01B

P3

Completed

Oncology Solid Tumor Unspecified

2016-11-28

2019-03-20

Treatments

NCT01972750

TKI258

P1

Unknown status

Glioblastoma

2016-11-01

2019-03-20

Treatments

NCT02268435

AMC1401

P1

Withdrawn

Gastrointestinal Stromal Tumors

2016-08-01

2019-03-20

Treatments

NCT01921673

AMC1302

P2

Completed

Gastrointestinal Cancer

2016-06-01

2019-03-19

Treatments

2014-000368-17

2014-000368-17

P2

Completed

Oncology Solid Tumor Unspecified

2016-04-07

2025-06-25

Treatments

NCT01635907

UPCC 23811

P2

Completed

Pheochromocytoma|Paraganglioma

2016-03-01

2023-03-30

Primary Endpoints|Treatments

NCT01719549

GASDOVI-1

P2

Completed

Gastrointestinal Cancer

2016-02-01

2019-03-19

Treatments

NCT01676714

UCDCC#231

P2

Completed

Non-Small-Cell Lung Cancer|Colorectal Cancer

2016-01-01

2019-03-19

Treatments

NCT01831726

SIGNATURE

P2

Completed

Ovarian Cancer|Gastrointestinal Cancer|Acute Myeloid Leukemia|Gastrointestinal Stromal Tumors|Thyroid Cancer|Head and Neck Cancer|Melanoma|Non-Small-Cell Lung Cancer

2015-12-01

2019-03-19

Treatments

NCT01266070

NCI-2011-00305

P2

Terminated

von Hippel-Lindau Disease

2015-12-01

2019-03-19

Treatments

NCT01484041

LCCC 2010-535

P2

Terminated

Breast Cancer

2015-12-01

2019-03-19

Treatments

NCT01262027

NCI-2011-00299

P2

Completed

Inflammatory Breast Cancer

2015-11-25

2019-08-10

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status

NCT02048943

I 242513

P1

Withdrawn

Pancreatic Cancer|Adenocarcinoma

2015-11-01

2019-03-20

Treatments

NCT01678105

DOVE

P2

Completed

Adenoid Cystic Carcinoma|Salivary Gland Cancer

2015-09-01

2019-03-19

Treatments

NCT01497392

I 175610

P1

Completed

Pancreatic Cancer|Adenocarcinoma

2015-08-31

2024-06-26

Primary Endpoints|Treatments

NCT01791387

DILIGENCE-1

P2

Unknown status

Renal Cell Carcinoma

2015-06-01

2019-03-19

Treatments

NCT01769547

DOVE-M

P2

Terminated

Mesothelioma

2015-06-01

2019-03-19

Treatments

NCT02108782

RU021205I

P2

Withdrawn

Pancreatic Cancer|Neuroendocrine Tumors|Somatostatinoma|Glucagonoma|Gastrinoma|Islet Cell Carcinoma|Neuroendocrine Carcinoma|Insulinoma|Islet Cell Adenoma

2015-05-01

2019-03-22

Treatments

2011-001230-42

2011-001230-42

P2

Completed

Breast Cancer

2015-04-03

2022-03-13

Treatments