# Glasdegib

Glasdegib (Daurismo, Pfizer Europe MA EEIG) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Acute myeloid leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + low-dose cytarabine | 1st line | Not candidates for standard induction chemotherapy |

## Products

### Daurismo

- Company: Pfizer Europe MA EEIG
- Target: Smoothened inhibitor
- Class: Other antineoplastic agents
- ATC: L01XX63
- EU approval: 26 Jun 2020
- Label revised: 7 May 2025
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/daurismo-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/daurismo-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/daurismo

Mechanism (SmPC section 5.1): Binds to Smoothened (SMO) to inhibit Hedgehog signal transduction, reducing GLI transcription factor activity and downstream pathway signalling.

## Label wording

- **Glasdegib** (Daurismo), Acute myeloid leukaemia, 1st line: “Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/daurismo-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/glasdegib