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TAK-662

Phase 1

Congenital Protein C Deficiency | Small molecule | Rare Disease |Takeda Pharmaceutical Company Limited|Last Updated: May 7, 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
UNCONTROLLED
Total Trials1
Total Enrollment5
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04984889A Study of TAK-662 for Japanese Patients With Congenital Protein C DeficiencyPHASE1 COMPLETED 5 — — Sep 7, 2021Oct 31, 2024May 7, 20254 Japan
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Study Endpoints
Primary Endpoints
PK Part: Protein C Activity Level of TAK-662
Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

Protein C is a vitamin K-dependent plasma protein and is an important component of the coagulation system. Protein C activity level was measured by chromogenic assays. Protein C activity level of TAK-662 was reported.

PK Part: Terminal Phase Elimination Half-life (t1/2) of TAK-662
Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

t1/2 of TAK-662 was reported.

PK Part: Incremental Recovery (IR) of TAK-662
Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

IR of TAK-662 was reported measured in terms of international unit per milliliter/ international unit per kilogram (IU/mL)/(IU/kg).

PK Part: Percentage of In-vivo Recovery (IVR) of TAK-662
Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

IVR corrected for plasma was determined using the formula: IVR (percentage \[%\])= (Maximum observed plasma concentration (Cmax) \[IU/mL\] - Concentration (C) pre-infusion \[IU/mL\]) \* Plasma volume pre-infusion (PV) milliliter (mL)/ Dose (international unit \[IU\])\*100 where Cmax was the observed Cmax value before baseline correction. IVR of TAK-662 measured in terms of percentage was reported.

PK Part: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of TAK-662
Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

AUClast of TAK-662 was reported measured in terms of international unit\*hour per milliliter (IU\*h/ml).

PK Part: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-infinity) of TAK-662
Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

AUC0-infinity of TAK-662 was reported.

PK Part: Maximum Observed Plasma Concentration (Cmax) of TAK-662
Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

Cmax of TAK-662 was reported.

PK Part: Time to Reach the Maximum Plasma Concentration (Tmax) of TAK-662
Pre-infusion, 0.5, 1, 2, 4, 8, 12, 24, and 36 hours post-infusion

Tmax of TAK-662 was reported.

Secondary Endpoints
PK and Extension Parts: Number of Participants With Treatment-Related Adverse Experiences (AEs)
PK Part: From the start of study drug administration up to Day 7; Extension Part: From the first dose of study drug administration in the Extension Part up to 35 months
Extension Part: Number of Episode Rated as Effective, Effective With Complications, or Not Effective on Efficacy Rating Scale During On-Demand Treatment
Extension Part: From the first dose of TAK-662 on-demand treatment in the Extension Part up to 35 months
Extension Part: Percentage of Surgical Episodes During Short-Term Prophylaxis That is Free of Presentations of PF or Thromboembolic Complications
Extension Part: From the first dose of TAK-662 short-term prophylaxis treatment in the Extension Part up to 35 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TAK-662 80 IU/kgEXPERIMENTALTAK-662 80 international unit (IU)/kg, single intravenous infusion over 15 minutes on Day 1. In the extension part, dose of TAK-662 will be modified per participants. TAK-662 is Protein C Concentrate, which is a lyophilized, sterile concentrate of human protein C.
Interventions
NameTypeDescription
TAK-662DRUGLyophilized, sterile concentrate of human protein C
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: PK Part: 1. Male and female participants with Japanese nationality. 2. A diagnosis of congenital protein C deficiency (homozygous or compound heterozygous). 3. Asymptomatic participant. 4. Oral anticoagulants allowed to be received. Extension part: 1. Participants who partici...

Countries:Japan
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