Sonidegib

Overview

Sonidegib is a Hedgehog signaling pathway inhibitor (via smoothened antagonism) developed as an anticancer agent by Novartis. It was FDA approved in 2015 for the treatment of basal cell carcinoma.

Indication

用于治疗那些在手术后或放射治疗后出现病情复发，或是不适合采用手术或放射治疗的局部晚期基底细胞癌（BCC）患者。BCC是常见皮肤癌，占所有非黑色素瘤病例的80%。

Associated Conditions

Refractory, locally advanced Basal cell carcinoma

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Sonidegib in Adult Patients with Locally Advanced Basal Cell Carcinoma (laBCC) in China	2025/03/18	NCT06880848	Phase 4	Active, not recruiting	Jemincare
AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma	2022/12/30	NCT05669339	Phase 2	Suspended	University of Florida
Oral Hedgehog Inhibitors in the Treatment of Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study	2022/07/19	NCT05463757	N/A	Recruiting	Maastricht University Medical Center
Tailored Sonidegib Schedule After Complete Response in BCC	2021/03/19	NCT04806646	Phase 2	Recruiting	Gruppo Oncologico del Nord-Ovest
Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma	2020/05/26	NCT04402073	Phase 2	Active, not recruiting	European Organisation for Research and Treatment of Cancer - EORTC
Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma	2019/08/26	NCT04066504	N/A	Completed	Sun Pharmaceutical Industries Limited
Sonidegib and Pembrolizumab in Treating Patients with Advanced Solid Tumors	2019/07/05	NCT04007744	Phase 1	Active, not recruiting	Mayo Clinic
A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma	2018/05/23	NCT03534947	Phase 2	Recruiting	Melanoma Institute Australia
SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors	2018/02/15	NCT03434262	Phase 1	Completed	St. Jude Children's Research Hospital
Pilot Study of Sonidegib and Buparlisib in Treating Patients With Advanced or Metastatic Basal Cell Carcinoma	2014/11/27	NCT02303041	Phase 2	Terminated	Anne Chang

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
Odomzo	Sun Pharmaceutical Industries Europe B.V.,Polarisavenue 87,2132JH Hoofddorp,The Netherlands	Authorised	8/14/2015

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
Sonidegib Phosphate Capsules	SUN PHARMACEUTICAL INDUSTRIES LIMITED	国药准字HJ20210061	化学药品	胶囊剂	7/20/2021

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.

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• Cemiplimab demonstrates efficacy in patients with locally advanced or metastatic basal cell carcinoma (mBCC) who have progressed on or are intolerant to hedgehog pathway inhibitors (HHIs). • The phase 2 Study 1620 showed a 22% overall response rate by independent central review, with a median progression-free survival of 10 months in advanced BCC patients treated with cemiplimab. • Common adverse events associated with HHIs, such as muscle spasms, taste changes, and weight loss, often lead to treatment discontinuation, highlighting the need for alternative therapies like cemiplimab. • Immunotherapy with cemiplimab presents a viable option for advanced BCC patients, particularly those who cannot tolerate or have progressed on HHIs, with manageable safety profiles and durable responses.

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Sonidegib phosphate (Odomzo), currently approved for locally advanced basal cell carcinoma, is being investigated for multiple additional cancer indications including gastroesophageal junction adenocarcinoma and medulloblastoma.

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