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KSHN001126

Phase 1

Healthy Postmenopausal Women | Small molecule | Other |Amneal Pharmaceuticals, Inc.|Last Updated: Feb 19, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06467201SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of AMN1126 in Healthy Post-Menopausal FemalesPHASE1 COMPLETED 18 — — Jun 3, 2024Mar 12, 2025Feb 19, 20262 United States, India
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Study Endpoints
Primary Endpoints
Type, incidence, severity, seriousness, and relatedness of Adverse Events (AEs)
Upto Day 15 after dosing

Adverse events reported after dosing will be evaluated

Number of participants with abnormal laboratory tests results
Upto Day 15 after dosing

Laboratory abnormalities after dosing will be evaluated

Number of participants with abnormal vital signs
Upto Day 15 after dosing
Number of participants with abnormal Electrocardiogram readings
Upto Day 15 after dosing

Impact on QTc interval will be evaluated

Secondary Endpoints
Evaluate the Peak Plasma Concentration (Cmax) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126
72 hours after dosing
Evaluate the Area under the plasma concentration versus time curve (AUC) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126
72 hours after dosing
Evaluate the Time to maximum concentration (Tmax) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126
72 hours after dosing
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
KSHN001126 150mgEXPERIMENTALLow Dose
KSHN001126 300mgEXPERIMENTALMid Dose
KSHN001126 600mgEXPERIMENTALHigh Dose
Interventions
NameTypeDescription
KSHN001126 150mgDRUG6 subjects will receive single oral dose of 150mg
KSHN001126 300mgDRUG6 subjects will receive single oral dose of 300mg
KSHN001126 600mgDRUG6 subjects will receive single oral dose of 600mg
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Eligibility Criteria
Age Range45 Years — 60 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Able to provide written Informed Consent and communicate with the investigator and comprehend study-related procedures. 2. Healthy, postmenopausal females aged 45 to 60 years old (inclusive), as determined by medical history and physical examination. 3. Body Mass Index at scr...

Countries:United StatesIndia
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