unasnemab (MT-3921) / Mitsubishi Tanabe, Osaka University - LARVOL DELTA

Virus-induced RGMa expression drives neurodegeneration in HTLV-1-associated myelopathy. (PubMed, JCI Insight) - "We demonstrated that HTLV-1-infected cells in HAM inflict neuronal damage via RGMa. Crucially, the neutralizing antibody against RGMa, unasnemab/MT-3921, effectively mitigated this damage in a dose-responsive manner, highlighting RGMa's pivotal role in neuronal damage and its potential as a therapeutic target for alleviating neuronal damage in HAM."

Journal • CNS Disorders • Genetic Disorders • Infectious Disease • CD4

Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury (clinicaltrials.gov) - P2 | N=72 | Completed | Sponsor: Mitsubishi Tanabe Pharma America Inc. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Orthopedics

Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury (clinicaltrials.gov) - P2 | N=72 | Active, not recruiting | Sponsor: Mitsubishi Tanabe Pharma America Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Orthopedics

Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Mitsubishi Tanabe Pharma America Inc. | Trial completion date: Jun 2024 ➔ Feb 2025 | Trial primary completion date: Mar 2024 ➔ Nov 2024

Trial completion date • Trial primary completion date • CNS Disorders • Orthopedics

Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Mitsubishi Tanabe Pharma America Inc. | Phase classification: P2a ➔ P2

Phase classification • CNS Disorders • Orthopedics

A Clinical Pharmacological Study of MT-3921 in Subjects With HTLV-1 Associated Myelopathy (HAM) (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: Mitsubishi Tanabe Pharma Corporation | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Oncology

A Clinical Pharmacological Study of MT-3921 in Subjects With HTLV-1 Associated Myelopathy (HAM) (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Mitsubishi Tanabe Pharma Corporation | Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Oncology

Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury (clinicaltrials.gov) - P2a | N=72 | Recruiting | Sponsor: Mitsubishi Tanabe Pharma Development America, Inc. | Trial completion date: Apr 2023 ➔ Jun 2024 | Trial primary completion date: Jan 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date • CNS Disorders • Orthopedics

A Clinical Pharmacology Study of MT-3921 in Healthy Adult Males (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Mitsubishi Tanabe Pharma Corporation | Recruiting ➔ Completed

Trial completion

A Clinical Pharmacology Study of MT-3921 in Healthy Adult Males (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Mitsubishi Tanabe Pharma Corporation | Not yet recruiting ➔ Recruiting

Enrollment open

A Clinical Pharmacology Study of MT-3921 in Healthy Adult Males (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Mitsubishi Tanabe Pharma Corporation

New P1 trial

A Clinical Pharmacological Study of MT-3921 in Subjects With HTLV-1 Associated Myelopathy (HAM) (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Mitsubishi Tanabe Pharma Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Oncology

A Clinical Pharmacological Study of MT-3921 in Subjects With HTLV-1 Associated Myelopathy (HAM) (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Mitsubishi Tanabe Pharma Corporation

New P1 trial • Hematological Malignancies • Leukemia • Oncology

Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury (clinicaltrials.gov) - P2a; N=72; Recruiting; Sponsor: Mitsubishi Tanabe Pharma Development America, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Orthopedics

Safety and Pharmacokinetics Study of MT-3921 in Spinal Cord Injury (clinicaltrials.gov) - P1; N=3; Completed; Sponsor: Mitsubishi Tanabe Pharma Development America, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • CNS Disorders • Complement-mediated Rare Disorders • Orthopedics

Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury (clinicaltrials.gov) - P2a; N=72; Not yet recruiting; Sponsor: Mitsubishi Tanabe Pharma Development America, Inc.

Clinical • New P2a trial • CNS Disorders • Complement-mediated Rare Disorders • Orthopedics

Safety and Pharmacokinetics Study of MT-3921 in Spinal Cord Injury (clinicaltrials.gov) - P1; N=3; Active, not recruiting; Sponsor: Mitsubishi Tanabe Pharma Development America, Inc.; Recruiting ➔ Active, not recruiting; Trial primary completion date: Oct 2020 ➔ Jan 2021

Clinical • Enrollment closed • Trial primary completion date • CNS Disorders • Complement-mediated Rare Disorders • Orthopedics

Safety and Pharmacokinetics Study of MT-3921 in Spinal Cord Injury (clinicaltrials.gov) - P1; N=6; Recruiting; Sponsor: Mitsubishi Tanabe Pharma Development America, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Oct 2019 ➔ Jan 2020

Clinical • Enrollment open • Trial initiation date