Trade names Odomzo Routes of
administration By mouth (capsules) Legal status US: ℞-only Molar mass 485.498 g/mol | AHFS/Drugs.com Odomzo ATC code L01XX48 (WHO) Bioavailability <10% | |
Route Oral administration (Capsule) | ||
Sonidegib (INN), also known as LDE225 and marketed as Odomzo, is a Hedgehog signaling pathway inhibitor (via smoothened antagonism) being developed as an anticancer agent by Novartis.
Contents
Approvals and indications
It was approved by the FDA for treating basal-cell carcinoma in July 2015 and is awaiting approval in the EU. In the EU, the agent has received positive opinion from the CHMP for approval.
It is indicated for the treatment of adult patients with locally advanced basal-cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
Pharmacology
Sonidegib is administered orally. Common side effects include muscle spasms, hair loss, fatigue, abdominal pain, nausea, headache, and weight loss.
Sonidegib binds to and inhibits smoothened to inhibit activation of the Hedgehog pathway. Sonidegib is primarily metabolized by CYP3A and is eliminated hepatically.
Development
It has been investigated as a potential treatment for:
It has demonstrated significant efficacy against melanoma in vitro and in vivo. It also demonstrated efficacy in a mouse model of pancreatic cancer.