Lysodren

(Mitotane)

Phase 3Small molecule

Lysodren is one of 8 small molecule programs targeting ENSAT Stage I Adrenal Cortex Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

ENSAT Stage I Adrenal Cortex CarcinomaRecruiting

Adrenal Cortical CarcinomaRecruiting

ENSAT Stage I Adrenal Cortex CarcinomaPhase 3

Recruiting

Adrenal Cortical CarcinomaPhase 2

Recruiting

Competition

Competitive Landscape

6 competitors in Adrenal Cortical Carcinoma

#DrugCompanyPhaseTrials

Cabometyx

Bristol-Myers Squibb

Phase 2

2 2

Keytruda

Merck & Co.

Phase 2

1 3

Cometriq

EExelixis

Phase 2

1 4

Tuoyi

SSun Yat-sen University

Phase 2

1 5

Lysodren

TTerezinha de Jesus Esteves Barata

Phase 3

1 6

Apatinib

LLaNova Medicines Zhejiang Co., Ltd.

Phase 2

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

Timeline

Expected Milestones

Q1 2029

Phase 3Recruiting

ENSAT Stage I Adrenal Cortex Carcinoma

NCT03583710

Q4 2031

Phase 2Recruiting

Adrenal Cortical Carcinoma

NCT06831175

Clinical

Trials by Indication[1]

Adrenocortical Carcinoma3 trials

A Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Mitotane in Patients With Advanced Adrenocortical Carcinoma

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT05634577·3 enrolled

The Impact of Mitotane Therapy on Serum Free Proteins in Patients With Adrenocortical Carcinoma

Completed·KKing's College Hospital NHS Trust··NCT05344027·35 enrolled

Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT)

Completed·CCollaborative Group for Adrenocortical Carcinoma Treatment·Phase 3·NCT00094497·304 enrolled

Chemotherapy1 trial

Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor

Completed·CChildren's Oncology Group·Phase 3·NCT00304070·78 enrolled

Adrenal Cortical Carcinoma1 trial

Phase II Study of PD-1 Inhibitor Combined With Apatinib and Mitotane in the Treatment of Advanced Adrenal Cortical Carcinoma

Recruiting·WWest China Hospital·Phase 2·NCT06831175·28 enrolled

Treatment1 trial

Efficacy of Adjuvant Mitotane Treatment (ADIUVO)

Unknown status·UUniversity of Turin, Italy·Phase 3·NCT00777244·200 enrolled

Metastatic1 trial

IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT00778817·20 enrolled

2 more indications

Prostate Cancer1 trial

A Safety and Feasibility Study of Mitotane in Prostate Cancer

Completed·UUniversity Health Network, Toronto·Phase 1·NCT02057237·1 enrolled

ENSAT Stage I Adrenal Cortex Carcinoma1 trial

A Randomized Registry Trial of Adjuvant Mitotane vs. Mitotane With Cisplatin/Etoposide After Primary Surgical Resection of Localized Adrenocortical Carcinoma With High Risk of Recurrence (ADIUVO-2 Trial)

Recruiting·MM.D. Anderson Cancer Center·Phase 3·NCT03583710·240 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

LYSODREN

NDA NDA016885

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Mitotane. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Mitotane compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Mitotane. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA016885). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Terezinha de Jesus Esteves Barata company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: TTerezinha de Jesus Esteves Barata

Lysodren

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2029

Q4 2031

Trials by Indication[1]

Adrenocortical Carcinoma3 trials

Chemotherapy1 trial

Adrenal Cortical Carcinoma1 trial

Treatment1 trial

Metastatic1 trial

Prostate Cancer1 trial

ENSAT Stage I Adrenal Cortex Carcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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