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.

openfdaRegulatory2 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2017-09-18 (see label)	approved	Sep 18, 2017	openfda
US FDA	Basal Cell Carcinoma	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 )	approved	Jul 24, 2015	openfda

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 11 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 14 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