NDAORALCAPSULE
Approved
Jul 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
5/8 — Partial
ODOMZO (sonidegib) by Fosun Pharma is pathway. First approved in 2015.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ODOMZO (sonidegib) is an oral small-molecule Hedgehog pathway inhibitor that binds to and inhibits Smoothened, a key transmembrane protein in Hh signal transduction. It is indicated for locally advanced basal cell carcinoma in patients who are not candidates for surgery or radiation. The drug represents a precision oncology approach to a rare skin cancer subset.
$0.029BPart D
Peak9.8 years to LOEPeak-stage product with modest Medicare spending ($29M) suggests stable but niche market penetration; team size likely right-sized to indication population.
Mechanism of Action
pathway. Sonidegib binds to and inhibits Smoothened, a transmembrane protein involved in Hh signal transduction.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Pilot Study of Sonidegib and Buparlisib in Treating Patients With Advanced or Metastatic Basal Cell Carcinoma
Started Feb 2015
10 enrolled
Carcinoma, Basal CellRecurrent Skin CancerSkin Neoplasms+1 more
Safety/Efficacy Study of LDE225 (Sonidegib) Plus Bortezomib in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
Started Jan 2015
7 enrolled
Multiple Myeloma
Study of LDE225 (Sonidegib) in Combination With Docetaxel in Triple Negative (TN) Advanced Breast Cancer (ABC) Patients
Started May 2014
12 enrolled
Advanced Breast Cancer
Sonidegib and Lenalidomide After Stem Cell Transplant in Treating Patients With Multiple Myeloma
Started Jan 2014
28 enrolled
Recurrent Plasma Cell MyelomaRefractory Plasma Cell Myeloma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.