Odomzo

(Sonidegib)

Phase 2Small molecule

Sun Pharmaceutical Industries, Inc.

Odomzo is one of 63 small molecule programs targeting Patients With Advanced Solid Tumors. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Patients With Advanced Solid TumorsActive, not recruiting

Hepatocellular CarcinomaRecruiting

Patients With Advanced Solid TumorsPhase 1

Active, not recruiting

Hepatocellular CarcinomaPhase 2

Recruiting

Competition

Competitive Landscape

265 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

Odomzo

Sun Pharmaceutical Industries, Inc.

Phase 2

1 2

Sovaldi

Gilead

Preclinical

1 3

Cysteine Hydrochloride

Novartis

Preclinical

1 4

Ibrance

Pfizer

Preclinical

1 5

Hepsera

Doptelet

1 7

Miraclid

TTechpool Bio-Pharma Co., Ltd.

Preclinical

1 8

Vermox

WWim Janssens

Preclinical

1 9

Valemetostat

Bristol-Myers Squibb

Preclinical

1 10

Alcohol

Astellas

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Recruiting

Basal Cell Carcinoma

NCT05463757

Q2 2027

Phase 2Recruiting

Hepatocellular Carcinoma

NCT05669339

Q3 2027

Phase 1Active, not recruiting

Patients With Advanced Solid Tumors

NCT04007744

Clinical

Trials by Indication[1]

Basal Cell Carcinoma4 trials

Pilot Study of Sonidegib and Buparlisib in Treating Patients With Advanced or Metastatic Basal Cell Carcinoma

Terminated·AAnne Chang·Phase 2·NCT02303041·10 enrolled

Dose-Modulated Sonidegib Therapy for Periocular Basal Cell Carcinoma

Completed·FFederico II University··NCT07068568·12 enrolled

A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma

Completed·MMelanoma Institute Australia·Phase 2·NCT03534947·16 enrolled

Show 1 more trial

Oral Hedgehog Inhibitors in the Treatment of Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study

Recruiting·MMaastricht University Medical Center··NCT05463757·80 enrolled

Medulloblastoma1 trial

Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma

Terminated·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT04402073·20 enrolled

Patients With Advanced Solid Tumors1 trial

Sonidegib and Pembrolizumab in Treating Patients With Advanced Solid Tumors

Active, not recruiting·MMayo Clinic·Phase 1·NCT04007744·36 enrolled

Myeloid Malignancies1 trial

Azacitidine and Sonidegib or Decitabine in Treating Patients With Myeloid Malignancies

Completed·MMayo Clinic·Phase 1·NCT02129101·63 enrolled

Complete Response1 trial

Tailored Sonidegib Schedule After Complete Response in BCC

Unknown status·GGruppo Oncologico del Nord-Ovest·Phase 2·NCT04806646·21 enrolled

4 more indications

Brain Tumors1 trial

SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT03434262·68 enrolled

Locally Advanced1 trial

Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma

Completed· Sun Pharmaceutical Industries Limited logo

Sun Pharmaceutical Industries Limited··NCT04066504·323 enrolled

Multiple Myeloma1 trial

Sonidegib and Lenalidomide After Stem Cell Transplant in Treating Patients With Multiple Myeloma

Completed·MMayo Clinic·Phase 2·NCT02086552·28 enrolled

Hepatocellular Carcinoma1 trial

AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma

Recruiting·UUniversity of Florida·Phase 2·NCT05669339·12 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 24, 2015

ODOMZO

NDA NDA205266

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Sonidegib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sonidegib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sonidegib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA205266). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Odomzo. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Sun Pharmaceutical Industries, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Sun Pharmaceutical Industries, Inc.

Patent Landscape[5]

Patent Cliff

Jul 24, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8178563Jul 24, 2029

8063043Sep 15, 2029

10266523Mar 30, 2036

Odomzo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Trials by Indication[1]

Basal Cell Carcinoma4 trials

Medulloblastoma1 trial

Patients With Advanced Solid Tumors1 trial

Myeloid Malignancies1 trial

Complete Response1 trial

Brain Tumors1 trial

Locally Advanced1 trial

Multiple Myeloma1 trial

Hepatocellular Carcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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