Sorafenib

Overview

Sorafenib is a bi-aryl urea and an oral multikinase inhibitor. It targets cell surface tyrosine kinase receptors and downstream intracellular kinases that are implicated in tumour cell proliferation and tumour angiogenesis. First approved by the FDA and European Commission in 2007 for the treatment of hepatocellular carcinoma, sorafenib is also indicated to treat renal carcinoma and differentiated thyroid carcinoma.

Indication

Sorafenib is indicated for the treatment of unresectable hepatocellular carcinoma and advanced renal cell carcinoma. In the US, it is also indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment.

Associated Conditions

Advanced Renal Cell Carcinoma
Angiosarcoma
Gastrointestinal Stromal Tumor (GIST)
Leiomyosarcoma (LMS)
Unresectable Hepatocellular Carcinoma (HCC)
Progressive, locally recurrent radioactive iodine-refractory Differentiated Thyroid Carcinoma (DTC)
Progressive, metastatic radioactive iodine-refractory Differentiated Thyroid Carcinoma (DTC)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Assess the Pharmacokinetics of Sorafenib in Mesoporous Magnesium Carbonate (DPH001) Compared to Nexavar® (sorafenib) in Healthy Volunteers	2025/01/28	NCT06797427	Early Phase 1	Completed	Disruptive Pharma
IB/IIa Study of MG-K10 in Adolescent Moderately Severe Patients	2025/01/09	NCT06765005	Phase 1	Recruiting	Shanghai Mabgeek Biotech.Co.Ltd
Combination of Toripalimab and JS004 Therapy for ccRCC	2024/11/15	NCT06690697	Phase 2	Recruiting	Fudan University
Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen	2024/08/01	NCT06532084	Phase 2	Recruiting	St. Petersburg State Pavlov Medical University
Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma	2024/07/30	NCT06527495	Phase 1	Recruiting	Assiut University
Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer	2024/07/01	NCT06482086	Phase 2	Recruiting	West China Hospital
A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating with Decitabine in Pediatric Relapsed and Refractory Acute Leukemias	2024/06/26	NCT06474663	Phase 1	Not yet recruiting	M.D. Anderson Cancer Center
Phase 2 Study of WGI-0301 for Advanced HCC	2024/03/13	NCT06309485	Phase 2	Not yet recruiting	Zhejiang Haichang Biotech Co., Ltd.
Efficacy and Safety of Sorafenib in New-Onset Type 1 Diabetes Mellitus	2024/01/26	NCT06227221	Phase 2	Not yet recruiting	Second Xiangya Hospital of Central South University
Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML	2024/01/24	NCT06221683	Phase 2	Recruiting	Children's Hospital of Soochow University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
sorafenib	Golden State Medical Supply, Inc.	51407-760	ORAL	200 mg in 1 1	12/19/2023
sorafenib	TWi Pharmaceuticals USA, Inc.	24979-715	ORAL	200 mg in 1 1	10/23/2023
Sorafenib	Teva Pharmaceuticals, Inc.	0480-5425	ORAL	200 mg in 1 1	7/1/2022
Nexavar	Bayer HealthCare Pharmaceuticals Inc.	50419-489	ORAL	200 mg in 1 1	8/28/2023
Sorafenib Tosylate	Mylan Pharmaceuticals Inc.	0378-1201	ORAL	200 mg in 1 1	11/15/2021
sorafenib	Dr.Reddys Laboratories Inc	43598-458	ORAL	200 mg in 1 1	11/18/2022
Nexavar	Bayer HealthCare Pharmaceuticals Inc.	50419-488	ORAL	200 mg in 1 1	8/28/2023
Sorafenib	Torrent Pharmaceuticals Limited	13668-682	ORAL	200 mg in 1 1	4/20/2023
sorafenib	Yabao Pharmaceutical Co., Ltd. Beijing	51990-201	ORAL	200 mg in 1 1	2/17/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Sorafenib Accord	Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN	Authorised	11/9/2022
Sorafenib Accord	Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN	Authorised	11/9/2022
Nexavar	Bayer AG,Kaiser-Wilhelm-Allee 1,51373 Leverkusen,Germany	Authorised	7/19/2006

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
NEXAVAR TABLET 200 mg	BAYER AG	SIN13339P	TABLET, FILM COATED	200 mg	8/24/2007
INFENIB FILM COATED TABLET 200MG	Remedica Ltd, PharOS MT Ltd	SIN16485P	TABLET, FILM COATED	200.00 mg	5/6/2022
SORAFENIB ALVOGEN FILM COATED TABLETS 200MG	Remedica Ltd, PHAROS MT LTD.	SIN16442P	TABLET, FILM COATED	200.00 mg	3/9/2022
SORAVAR 200 FILM COATED TABLET 200 MG	Intas Pharmaceuticals Limited	SIN16774P	TABLET, FILM COATED	200 mg	5/10/2023

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
NEXAVAR sorafenib 200 mg (as tosilate) tablet blister pack	123158	Bayer Australia Ltd	Medicine	A	9/27/2006

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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