Sonidegib

Hedgehog Pathway Inhibitor — ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Key facts

Sonidegib is an onp drug in the Hedgehog Pathway Inhibitor class catalogued in DrugCentral. It was first approved by the EMA in 2015. Its mechanism of action is classified as Smoothened Receptor Antagonists. DrugCentral lists 2 molecular targets, including Shh and SMO. Recorded indications include Basal cell carcinoma of skin.

• Approval status: onp (first approved 2015 by the EMA).
• Drug class: Hedgehog Pathway Inhibitor.
• Mechanism of action: Smoothened Receptor Antagonists.
• Molecular targets: Shh and SMO (2 listed in DrugCentral).
• Indications: Basal cell carcinoma of skin.
• ATC code: L01XJ02 (Hedgehog pathway inhibitors).
• Molecular formula: C26H26F3N3O3; molecular weight 485.51 g/mol.

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (1)

• Basal cell carcinoma of skin

Mechanism & targets

• Mechanism of action (MoA): Smoothened Receptor Antagonists
• Established pharmacologic class: Hedgehog Pathway Inhibitor

Molecular targets (2)

Target	Gene	Action	Activity
Sonic hedgehog protein	Shh	unknown	IC50 8.26
Smoothened homolog	SMO	antagonist	Ki 8.22

Regulatory approvals (2)

Date	Agency	Marketed as	Applicant	Orphan
2015-07-24	FDA	—	NOVARTIS PHARMS CORP
2015-06-25	EMA	—	—

ATC classification

ATC code	Therapeutic hierarchy
L01XJ02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › OTHER ANTINEOPLASTIC AGENTS › Hedgehog pathway inhibitors

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
Muscle spasms	250.6
Blood creatine phosphokinase increased	174.6
Dysgeusia	100.2
Alopecia	56.0
Death	54.2
Ageusia	52.2
Disease progression	44.9

Chemical structure

Full physicochemical, ADMET and 3D-structure analysis of Sonidegib is on its molecule page.

• Molecular formula: C₂₆H₂₆F₃N₃O₃
• Molecular weight: 485.51 g/mol
• CAS number: 956697-53-3
• InChIKey: VZZJRYRQSPEMTK-CALCHBBNSA-N
• PubChem CID: 24775005

C[C@H]1CN(C[C@@H](C)O1)C1=NC=C(NC(=O)C2=CC=CC(=C2C)C2=CC=C(OC(F)(F)F)C=C2)C=C1

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Sonidegib used for?

DrugCentral lists the following indications for Sonidegib: Basal cell carcinoma of skin.

How does Sonidegib work?

Sonidegib is classified as Smoothened Receptor Antagonists; its molecular targets in DrugCentral include Shh and SMO (antagonist).

When was Sonidegib first approved?

Sonidegib was first approved by the EMA in 2015.

What drug class does Sonidegib belong to?

Sonidegib is in the Hedgehog Pathway Inhibitor class.

What is the chemical formula of Sonidegib?

Sonidegib has the molecular formula C26H26F3N3O3 and a molecular weight of 485.51 g/mol.

Sources

• DrugCentral drug card 5008 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL2105737 — compound record and bioactivity
• PubChem CID 24775005 — chemical identifiers
• DrugBank DB09143 — drug record
• FDA UNII 0RLU3VTK5M — substance identity
• DailyMed: FDA labels for Sonidegib — current prescribing information (label search)
• UniProt Q99835 (SMO) — target protein
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral

How this page is built: methodology · editorial policy & corrections.