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SCH 58235

Phase 1

Hypercholesterolemia | Small molecule | Metabolic |Organon & Co.|Last Updated: Feb 16, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

SCH 58235 · 1 trial · 1 indication

Phase 1 1
NCT00653913Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED)Hypercholesterolemia
COMPLETED18 Analytics
PHASE1COMPLETED
Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED)
Hypercholesterolemia
NCT0065391318
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Study Endpoints

Primary Endpoints

Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin after administration of each drug alone and in combination, using Cmax and AUC(0-24h).
Day 7 of each period

Secondary Endpoints

Compare plasma concentrations of SCH 58235 (ezetimibe) and pitavastatin administration of each drug alone and in coadministration, using Tmax, plasma concentration 24 h after last dose, and AUC(I).
Day 7 of each period
Adverse events, laboratory tests results, and vital signs.
Throughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group AACTIVE_COMPARATORSCH 58235 (Period 1) Pitavastatin (Period 2) Coadministration (Period 3)
Group BACTIVE_COMPARATORSCH 58235 (Period 1) Coadministration (Period 2) Pitavastatin (Period 3)
Group CACTIVE_COMPARATORPitavastatin (Period 1) SCH 58235 (Period 2) Coadministration (Period 3)
Group DACTIVE_COMPARATORPitavastatin (Period 1) Coadministration (Period 2) SCH 58235 (Period 3)
Group EACTIVE_COMPARATORCoadministration (Period 1) SCH 58235 (Period 2) Pitavastatin (Period 3)
Group FACTIVE_COMPARATORCoadministration (Period 1) Pitavastatin (Period 2) SCH 58235 (Period 3)

Interventions

NameTypeDescription
SCH 58235DRUGSCH 58235 10 mg (once daily)
pitavastatinDRUGPitavastatin 2 mg (once daily)
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Eligibility Criteria

Age Range20 Years to 65 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy adult male subjects meeting all the criteria below or adult male subjects having no obvious disease other than high cholesterol levels. * Aged 20 years or over and 65 years or below when the informed consent is obtained. * Weighing 50 kg or over and 80 kg or below on t...

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Competitive Landscape -Dyslipidemia / Hypercholesterolemia 39 trials (matched to "Hypercholesterolemia")

CompanyTickerTrialsLead PhaseDrugs
Arrowhead Pharmaceuticals, Inc.ARWR7PHASE3zodasiran
Novartis AG Sponsored ADRNVS11PHASE3inclisiran
Merck & Co., Inc.MRK3PHASE3Enlicitide Decanoate
AstraZeneca PLCAZN1PHASE3AZD0780
Ionis Pharmaceuticals, Inc.IONS1PHASE3Olezarsen
Regeneron Pharmaceuticals, Inc.REGN2PHASE2Alirocumab
Eli Lilly and CompanyLLY1PHASE2Solbinsiran
MediciNova, Inc.MNOV1PHASE2MN-001
NewAmsterdam Pharma Company N.V.NAMS1PHASE1Obicetrapib
Verve Therapeutics, Inc.VERV3PHASE1VERVE-102
CRISPR Therapeutics AGCRSP1PHASE1CTX310
Esperion Therapeutics, Inc.ESPR1 - Bempedoic Acid
Ultragenyx Pharmaceutical, Inc.RARE1 - Undisclosed
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Frequently asked questions about SCH 58235

What is SCH 58235 used for?

SCH 58235 is a small molecule being developed for hypercholesterolemia, a condition of high cholesterol levels in the blood. It is in Phase 1 clinical development and is being studied in the metabolic therapeutic area.

Who makes SCH 58235?

SCH 58235 is being developed by Organon & Co., a company listed on the stock exchange under the ticker OGN. The drug is in Phase 1 clinical development for hypercholesterolemia.

What phase is SCH 58235 in?

SCH 58235 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed for the drug.

What clinical trials is SCH 58235 in?

SCH 58235 has one completed clinical trial, identified as NCT00653913. This Phase 1 study evaluated the potential for drug interaction between SCH 58235 (ezetimibe) and pitavastatin in 18 male participants with hypercholesterolemia.

Is SCH 58235 the same as ezetimibe?

SCH 58235 is also known as ezetimibe. The completed clinical trial NCT00653913 refers to SCH 58235 as ezetimibe, indicating that these names refer to the same drug.