recombinant-iduronate-2-sulfatase (JR-032) / GSK, JCR Pharma - LARVOL DELTA

A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT) (clinicaltrials.gov) - P3 | N=86 | Active, not recruiting | Sponsor: JCR Pharmaceuticals Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2026 ➔ Oct 2027 | Trial primary completion date: Jan 2026 ➔ Oct 2027

Enrollment closed • Trial completion date • Trial primary completion date • Hunter Syndrome

Genotype Analysis of the JR Blood Group in an East Asian Population Using Tetra-Primer ARMS-PCR. (PubMed, Ann Clin Lab Sci) - "The minor allele frequency of the ABCG2 null allele in the Korean cohort was 2.3%. The estimated genotype frequencies of homozygotes and heterozygotes for this null allele are 0.05% and 4.56%, respectively. The newly developed ARMS-PCR assay would be useful for determining the Jr(a-) antigen status in patients who produce anti-Jr(a) antibodies as well as for selecting Jr(a-) blood donors."

Journal • ABCG2

A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT) (clinicaltrials.gov) - P3 | N=80 | Recruiting | Sponsor: JCR Pharmaceuticals Co., Ltd. | Trial completion date: Oct 2026 ➔ Jan 2026 | Trial primary completion date: Oct 2026 ➔ Jan 2026

Trial completion date • Trial primary completion date • Hunter Syndrome

A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT) (clinicaltrials.gov) - P3 | N=80 | Recruiting | Sponsor: JCR Pharmaceuticals Co., Ltd. | Trial completion date: Jan 2026 ➔ Oct 2026 | Trial primary completion date: Jan 2026 ➔ Oct 2026

Trial completion date • Trial primary completion date • Hunter Syndrome

A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (clinicaltrials.gov) - P3 | N=80 | Recruiting | Sponsor: JCR Pharmaceuticals Co., Ltd. | Trial completion date: Aug 2024 ➔ Jan 2026 | Trial primary completion date: Aug 2024 ➔ Jan 2026

Trial completion date • Trial primary completion date • Hunter Syndrome

A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (clinicaltrials.gov) - P3 | N=80 | Recruiting | Sponsor: JCR Pharmaceuticals Co., Ltd. | N=50 ➔ 80

Enrollment change • Hunter Syndrome

A Phase Ⅲ Study of JR-141 in Patients With Mucopolysaccharidosis II (clinicaltrials.gov) - P3 | N=50 | Recruiting | Sponsor: JCR Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hunter Syndrome

A Phase Ⅲ Study of JR-141 in Patients With Mucopolysaccharidosis II (clinicaltrials.gov) - P3; N=50; Not yet recruiting; Sponsor: JCR Pharmaceuticals Co., Ltd.; Trial completion date: Mar 2024 ➔ Aug 2024; Initiation date: Mar 2021 ➔ Aug 2021; Trial primary completion date: Mar 2024 ➔ Aug 2024

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Hunter Syndrome

A Phase Ⅲ Study of JR-141 in Patients With Mucopolysaccharidosis II (clinicaltrials.gov) - P3; N=50; Not yet recruiting; Sponsor: JCR Pharmaceuticals Co., Ltd.

Clinical • New P3 trial • Hunter Syndrome