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Isomyosamine

Phase 2

Sarcopenia in Elderly | Small molecule | Other |TNF Pharmaceuticals, Inc.|Last Updated: Apr 24, 2025

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06942182Safety and Efficacy of Isomyosamine in Reducing Inflammation and Treating Muscle Loss in Older Adults After Hip or Thigh Bone FracturesPHASE2 NOT YET_RECRUITING 60May 1, 2025Mar 1, 2026Apr 24, 2025 -
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Study Endpoints
Primary Endpoints
Change in Short Physical Performance Battery (SPPB) Test in subjects treated with Isomyosamine or placebo
From enrollment to the end of treatment at 90 days
Secondary Endpoints
4-meter walk test
From enrollment to the end of treatment at 90 days
6-minute walk test
From enrollment to the end of treatment at 90 days
Grip strength
From enrollment to the end of treatment at 90 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Study Drug: 1000 mg IsomyosamineEXPERIMENTALSubjects randomly assigned to receive 1000 mg Isomyosamine daily via four 250 mg capsules
Placebo 1000 mgPLACEBO_COMPARATORSubjects randomly assigned to receive 1000 mg placebo daily via four 250 mg capsules
Interventions
NameTypeDescription
Isomyosamine 250mgDRUGIsomyosamine 250 mg capsules dosed 4 times daily
Placebo 250 mgDRUGPlacebo 250 mg capsule 4 times daily
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Eligibility Criteria
Age Range60 Years — 85 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Age 60 to 85 years of age 2. Non-complex, non-comminuted fracture of the femoral head, femoral neck, or acetabulum due to an accidental (non-neurologic or cardiovascular) fall 3. Concomitant medication limited to treatment for chronic conditions 4. The ability to give informe...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06942182primaryCompletionDate: changed
LOWMay 24, 2026NCT06942182studyFirstPostDate: changed