Sodium Thiosulfate

(Trans-tympanic injection of a sodium thiosulfate gel)

Phase 2Small molecule

OOrthopedic Foot and Ankle Center, Ohio

Sodium Thiosulfate is one of 29 small molecule programs targeting Ototoxicity. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

OtotoxicityActive, not recruiting

Peritoneal MesotheliomaRecruiting

OtotoxicityPhase 2

Active, not recruiting

Peritoneal MesotheliomaPhase 1

Recruiting

Competition

Competitive Landscape

34 competitors in Ototoxicity

#DrugCompanyPhaseTrials

Cysteine Hydrochloride

Novartis

Phase 3

3 2

Qualaquin

BBiomed Industries, Inc.

Approved

1 3

Atovaquone/proguanil

Pfizer

Approved

1 4

Artemether/lumefantrine

Merck & Co.

Approved

1 5

Crestor

AstraZeneca

Phase 2

1 6

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 2

1 7

N-Acetyl Cyteien

SStanford University

Phase 2

2 8

Ginkgo Biloba Extract

NNational Center for Complementary and Integrative Health (NCCIH)

Phase 2

1 9

Avlosulfon

AAlmirall, S.A.

Phase 1

1 10

Acetyl Cysteine

TTanta University

Phase 2

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

Timeline

Expected Milestones

Q4 2034

Phase 1Recruiting

Peritoneal Mesothelioma

NCT04847063

Clinical

Trials by Indication[1]

Ototoxicity1 trial

Efficacy of Trans-tympanic Injections of a Sodium Thiosulfate Gel to Prevent Cisplatin-induced Ototoxicity

Terminated·—·Phase 2·NCT02281006·13 enrolled

Peritoneal Mesothelioma1 trial

Individualized Response Assessment to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Primaries

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04847063·60 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 14, 1992

SODIUM THIOSULFATE

NDA NDA020166

Feb 14, 2012

SODIUM THIOSULFATE

NDA NDA203923

Sep 20, 2022

PEDMARK

NDA NDA212937

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Trans-tympanic injection of a sodium thiosulfate gel. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Trans-tympanic injection of a sodium thiosulfate gel compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Trans-tympanic injection of a sodium thiosulfate gel. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA212937). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Sodium Thiosulfate. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Orthopedic Foot and Ankle Center, Ohio company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: OOrthopedic Foot and Ankle Center, Ohio

Patent Landscape[5]

Patent Cliff

Jul 7, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10479686Jul 7, 2030

9585912Jul 7, 2030

9345724Jul 7, 2030

10596190Jan 5, 2038

11964018Jul 1, 2039

5 more patents

11992530Jul 1, 2039

11617793Jul 1, 2039

11998604Jul 1, 2039

11510984Jul 1, 2039

11291728Jul 1, 2039

Sodium Thiosulfate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2034

Trials by Indication[1]

Ototoxicity1 trial

Peritoneal Mesothelioma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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