Last reviewed 2026-04-20 · How we verify

SONIDEGIB

Sonidegib inhibits the Hh pathway by binding to and blocking Smoothened, a key transmembrane protein.

At a glance

Mechanism of action

Sonidegib works by targeting the Hedgehog (Hh) signaling pathway, which is important in cell growth and development. It specifically binds to and inhibits Smoothened, a protein that helps transmit signals within this pathway, thereby preventing abnormal cell growth.

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: EMBRYO-FETAL TOXICITY ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Verify the pregnancy status of females of reproductive potential prior to initiating therapy. Advise females of reproductive potential to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] . Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with ODOMZO and for at least 8 months after the last dose [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman and is embryotoxic, fetotoxic, and teratogenic in animals. ( 5.1 , 8.1 ) Verify the pregnancy status of females of reproductive potential prior to initiating therapy. Advise females of reproductive potential to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose. ( 5.1 , 8.3 ) Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with ODOMZO and for at least 8 months after the last dose. ( 5.1 , 8.3 )

Common side effects

• muscle spasms
• musculoskeletal pain
• myalgia
• alopecia
• pruritus
• dysgeusia
• headache
• fatigue
• pain
• nausea
• diarrhea
• abdominal pain

Key clinical trials

• Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma
• Sonidegib and Pembrolizumab in Treating Patients With Advanced Solid Tumors (PHASE1)
• AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma (PHASE2)
• Phase IB Trial of LDE225 and Paclitaxel in Recurrent Ovarian Cancer (PHASE1)
• Blue-Light Photodynamic Therapy and Sonidegib for Multiple Basal Cell Carcinomas (PHASE1)
• A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma (PHASE2)
• Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma (PHASE2)
• Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma (PHASE2)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• SONIDEGIB CI brief — competitive landscape report
• SONIDEGIB updates RSS · CI watch RSS