# Sonidegib

Sonidegib (Odomzo, Sun Pharmaceutical Industries Europe B.V.) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Basal cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Locally advanced | Not amenable to curative surgery or radiation therapy |

## Products

### Odomzo

- Company: Sun Pharmaceutical Industries Europe B.V.
- Target: Smoothened inhibitor
- Class: Hedgehog pathway inhibitors
- ATC: L01XJ02
- EU approval: 14 Aug 2015
- Label revised: 17 Nov 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/odomzo-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/odomzo-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/odomzo

Mechanism (SmPC section 5.1): Sonidegib binds to Smoothened, inhibiting Hedgehog signalling and blocking downstream signal transduction involved in proliferation, differentiation, and survival.

## Label wording

- **Sonidegib** (Odomzo), Basal cell carcinoma, locally advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/odomzo-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/sonidegib