Table 1.

Characteristics of sonidegib [14, 15]

Name	Sonidegib (Odomzo)
Class; mechanism of action	Antineoplastic; smoothened protein inhibitor
Date of approval	FDA: July 2015 EMA: August 2015
Treatment	Inoperable laBCC in patients aged ≥ 18 years
Dosage	200 mg/day oral capsule
Pharmacokinetics	Estimated 6% oral bioavailability; highly bound to human plasma proteins; high volume of distribution
Pharmacodynamics	GLI levels↓ GLI controlled transcription↓ Cellular proliferation↓
Adverse events	Muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia
Most important trial for approval	BOLT phase II trial