Sonidegib
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-SONIDEGIB |
|---|---|
| Type | Drug |
| Aliases | OdomzoСонідегіб |
| Status | reviewed 2026-05-04 | pending_clinical_signoff |
| Diseases | DIS-BCC |
| Sources | SRC-NCCN-SKIN-2025 |
Drug Facts
| Class | Hedgehog pathway inhibitor (SMO antagonist) |
|---|---|
| Mechanism | Oral SMO (Smoothened) antagonist; second-in-class after vismodegib. Same mechanism: blocks SMO-mediated HH signaling, preventing GLI1/GLI2 activation. BOLT trial established 200 mg daily as the approved dose (vs 800 mg — superior tolerability, maintained efficacy). ORR ~58% in laBCC (BOLT 200 mg, 30-month update). FDA-approved 2015. |
| Typical dosing | 200 mg PO once daily on an empty stomach (≥1 h before or ≥2 h after food). Continuous until progression or unacceptable toxicity. |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-05-04 |
Warnings
- Embryo-fetal toxicity — teratogenic, embryotoxic; contraindicated in pregnancy; two contraceptive methods required in females of reproductive potential
Notes
BOLT trial (Migden 2015 Lancet Oncol): 200 mg vs 800 mg daily in laBCC; both arms efficacious but 800 mg had significantly more musculoskeletal toxicity. 200 mg approved for locally advanced BCC (not metastatic BCC — FDA labeling restricted to laBCC). NCCN endorses sonidegib as an alternative to vismodegib for laBCC. Very long half-life (~28 days) means AEs persist weeks after discontinuation; teratogenicity counseling required for ~20 months after last dose in females.
Used By
Regimens
REG-SONIDEGIB-BCC- Sonidegib monotherapy (locally advanced BCC)