Sonidegib
Hedgehog Pathway Inhibitors
Sold as Odomzo
- Drug class
- Hedgehog Pathway Inhibitors
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 4
- FDA reports (12 mo)
- 251
Overview
Sonidegib is an active pharmaceutical ingredient in the Hedgehog Pathway Inhibitors group (L01XJ). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 1 | December 31, 2024 |
| EU European Union | EMA | 1 | January 20, 2026 |
| CA Canada | Health Canada | 1 | July 15, 2025 |
| GB United Kingdom | MHRA | 1 | May 15, 2026 |
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE ODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
ODOMZO is a hedgehog pathway inhibitor indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
( 1 )
How to take
EUEuropean Union· EMA
1 product
Uses
Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.
How to take
CACanada· Health Canada
1 product
Uses
ODOMZO (sonidegib) is indicated for: The treatment of adult patients with histologically confirmed locally advanced basal cell carcinoma (laBCC) that is not amenable to radiation therapy or curative surgery. The indication is granted market authorization based on objective response rate (ORR) demonstrated in a non-comparative Phase II trial (see Section 14 Clinical Trials).
Overall survival (OS) benefit in this trial cannot be confirmed. Distribution Restrictions ODOMZO is only available through a controlled distribution program called the ODOMZO Pregnancy Prevention Program. Under this program, only prescribers and pharmacies registered with the program are able to prescribe and dispense the product, respectively.
In addition, ODOMZO can only be dispensed to patients who are registered and meet all the conditions of the ODOMZO Pregnancy Prevention Program (OPPP). ca. 3 Pediatrics). 2 Geriatrics Geriatrics (≥65 years of age): No overall differences in effectiveness were observed between geriatric patients and younger patients.
GBUnited Kingdom· MHRA
1 product
1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [4].
Drug interactions
Known interactions involving Sonidegib. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 028312dc-d155-4f… · revised December 31, 2024 [PDF]
- [2]European Medicines Agency · EMEA/H/C/002839 · revised January 20, 2026
- [3]Health Canada (DPD) · 02500337 · revised July 15, 2025
- [4]MHRA (UK) · PLGB317500166 · revised May 15, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.