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NGI226

Phase 2

Achilles Tendinopathy | Small molecule | Other |Novartis AG|Last Updated: Mar 30, 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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05592990A Study to Investigate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles TendinopathyPHASE2 COMPLETED 45Jun 14, 2023Feb 3, 2026Mar 30, 20267 United States, France +1
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Study Endpoints
Primary Endpoints
Number of participants with AEs and SAEs
Up to Day 169 (End of Study)

AEs and SAEs including ECG parameters, Lab Chemistry and Hematology parameters, urinalysis, local tolerability

Secondary Endpoints
Changes in tendon stiffness from baseline at week 12 assessed by ultrasound (US)-based shear wave elastography (SWE)
Baseline, Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NGI226EXPERIMENTALsingle peritendon injection
PlaceboPLACEBO_COMPARATORsingle peritendon injection
Interventions
NameTypeDescription
NGI226DRUGNGI226 MP
PlaceboDRUGPlacebo MP
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Eligibility Criteria
Age Range30 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Written informed consent must be obtained prior to all study specific screening procedures, as close to the start of the screening period as possible. * Presence of clinically (local Achilles tendon pain on tendon-loading activities, pain on palpation at the level 2-6 cm proxi...

Countries:United StatesFranceGermany
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