Recent Updates
Recently added Catalysts

MT1013

Phase 2

Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis | Small molecule | Endocrine |Co-Diagnostics, Inc.|Last Updated: Feb 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment115
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06690242MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney DiseasePHASE2 COMPLETED 115 — — Nov 4, 2024Oct 15, 2025Feb 5, 20261 China
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Percentage of participants with > 30% reduction from baseline in mean iPTH during the efficacy assessment phase
Weeks 22 to 27, inclusive
Secondary Endpoints
Percentage of participants with > 50% reduction from baseline in mean iPTH during the efficacy assessment phase
Weeks 22 to 27, inclusive
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MT1013 dose regimen 1EXPERIMENTALMT1013 injection dose regimen 1 administered intravenously (IV) three times per week for 26 weeks.
MT1013 dose regimen 2EXPERIMENTALMT1013 injection dose regimen 2 administered intravenously (IV) three times per week for 26 weeks.
EtelcalcetideACTIVE_COMPARATOREtelcalcetide injection administered intravenously (IV) three times per week for 26 weeks.
PlaceboPLACEBO_COMPARATORPlacebo administered intravenously (IV) three times per week for 26 weeks;
Interventions
NameTypeDescription
MT1013DRUGMT1013 is a novel calcimimetic agent
Etelcalcetide HydrochlorideDRUGthe already-marketed therapeutic agents
PlaceboDRUGThe measure does not contain the active ingredients
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 1\. Subject capable of understanding written information ,willing to participate in, and provide a written informed consent; * 2.Male or female subjects must be at least 18 years old when signing the informed consent; * 3.The subjects must undergo regular maintenance hemodialy...

Countries:China
Unlock Eligibility Criteria