ODOMZO (sonidegib phosphate)
Odomzo treats adults with a type of skin cancer known as locally advanced basal cell carcinoma. It is used when the cancer has returned after a patient has already undergone surgery or radiation therapy. It also helps patients with this condition who are not able to receive surgery or radiation.
How ODOMZO Works
This drug works by blocking the Hedgehog signaling pathway. It binds to a specific protein called Smoothened, which is found in the cell membrane and is involved in sending signals through this pathway. By inhibiting this protein, the drug interferes with the transmission of these signals.
Details
- Status
- Prescription
- First Approved
- 2015-07-24
- Patent Cliff
- 2036
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ODOMZO Approval History
What ODOMZO Treats
1 indicationsODOMZO is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Basal Cell Carcinoma
ODOMZO Boxed Warning
EMBRYO-FETAL TOXICITY ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Verify the pregnancy status of females of reproductive potential prior to initiating therapy. Advise females of reproductive potential to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dos...
WARNING: EMBRYO-FETAL TOXICITY ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Verify the pregnancy status of females of reproductive potential prior to initiating therapy. Advise females of reproductive potential to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] . Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with ODOMZO and for at least 8 months after the last dose [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman and is embryotoxic, fetotoxic, and teratogenic in animals. ( 5.1 , 8.1 ) Verify the pregnancy status of females of reproductive potential prior to initiating therapy. Advise females of reproductive potential to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose. ( 5.1 , 8.3 ) Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with ODOMZO and for at least 8 months after the last dose. ( 5.1 , 8.3 )
ODOMZO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ODOMZO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ODOMZO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ODOMZO
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ODOMZO FDA Label Details
Indications & Usage
FDA Label (PDF)ODOMZO is indicated for the treatment of Basal Cell Carcinoma.
WARNING: EMBRYO-FETAL TOXICITY ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Verify the pregnancy status of ...
Pro Intelligence Preview
Deep insights for ODOMZO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.