Drug · Small Molecule

Sonidegib

CI-DRUG-00000555Explore in graph →NCIt C82385 CHEMBL2105737 CIViC Approved

Regulatory

Approvals (4)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as ODOMZO (DIN 02500337) under ATC L01XJ02 SONIDEGIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 23, 2020	health-canada-dpd

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 10 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	3	1	36	4	CA, EU, US	Jul 24, 2015	2009-03
Malignant Liver Neoplasm	Phase2	Phase 2	1	1	3	0	—	—	2011-02
Skin Carcinoma	Phase2	Phase 2	1	0	2	0	—	—	Jul 23, 2019
Leukemia	Phase2	Phase 2	0	0	2	0	—	—

Curated evidence

Clinical evidence (7)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–7 of 7 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
PTCH1 Loss-of-function1
Sonidegib	Basal Cell Carcinoma

Clinical trials

Trials with this intervention (39)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–39 of 39 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT05669339	AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma	recruiting	Phase 2	12	University of FloridaOTHER	1	Jul 14, 2026	clinicaltrials
NCT04806646	Tailored Sonidegib Schedule After Complete Response in BCC(SONIBEC)	active not recruiting	Phase 2

Molecule

Record

Kind: Small Molecule
Mechanism: Smoothened homolog inhibitor
Targets: 1 gene
UNII: W421AI34UW
Aliases: (1,1'-Biphenyl)-3-carboxamide, N-(6-((2R,6S)-2,6-dimethyl-4-morpholinyl)-3-pyridinyl)-2- Methyl-4'-(trifluoromethoxy)-, Rel-, Erismodegib, LDE 225, LDE225, NVP-LDE 225, NVP-LDE225, Odomzo, ODOMZO, Smoothened Antagonist LDE225, Sonidegib, Sonidegib Phosphate

Data updated 13 hours agoSource updated unknown

Identifiers

Codes (4)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01XJ02	SONIDEGIB
DIN (Health Canada)	02500337	ODOMZO
DPD drug code