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Methylconalamin

Phase 1

Therapeutic Equivalency, Healthy | Small molecule | Other |Co-Diagnostics, Inc.|Last Updated: Sep 5, 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07158099Bioequivalence Study of WP205 in Healthy SubjectsPHASE1 NOT YET_RECRUITING 14 — — Sep 15, 2025Sep 30, 2025Sep 5, 2025 - —
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Study Endpoints
Primary Endpoints
Peak Plasma Concentration (Cmax)
0 to 24 hours after each single intramuscular dose
Area under the plasma concentration versus time curve (AUC)0-t
0 to 24 hours after each single intramuscular dose
Area under the plasma concentration versus time curve (AUC)0-∞
0 to 24 hours after each single intramuscular dose
Secondary Endpoints
Safety
7 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTAL -
Group BACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Methylconalamin Injection(WP205)DRUG25 mg intramuscular injection in the upper-arm deltoid
Methylconalamin for InjectionDRUG25 mg intramuscular injection in the upper-arm deltoid
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: 1. Subjects have been fully informed of the study purpose, nature, procedures, and potential adverse reactions, voluntarily agree to participate, and have signed the informed consent form prior to any study-related procedures. 2. Male or female subjects aged 18 years or older, w...

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