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Mucopolysaccharidosis II

9
Pipeline Programs
9
Companies
19
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
3
2
2
2
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Gene Therapy
1100%
+ 19 programs with unclassified modality

Competitive Landscape

9 companies ranked by most advanced pipeline stage

JCR Pharmaceuticals
JCR PharmaceuticalsJapan - Hyogo
7 programs
1
2
2
2
JR-141Phase 31 trial
JR-141Phase 31 trial
JR-141Phase 2/31 trial
JR-141Phase 2/31 trial
JR-141Phase 21 trial
+2 more programs
Active Trials
NCT03128593Completed14Est. Oct 2017
NCT03708965Active Not Recruiting19Est. Dec 2027
NCT03359213Completed18Est. Oct 2019
+4 more trials
Sangamo Therapeutics
1 program
1
SB-913Phase 1/21 trial
Active Trials
NCT03041324Terminated9Est. May 2021
Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
1
lymphocyte gene therapyPhase 1/2Gene Therapy1 trial
Active Trials
NCT00004454Completed2
GC Biopharma
GC BiopharmaKorea - Yongin
3 programs
GC1123PHASE_11 trial
GC1111_0.5mg/kgPHASE_1_21 trial
idursulfase betaPHASE_21 trial
Active Trials
NCT05422482Active Not Recruiting12Est. Jun 2027
NCT01301898Completed31Est. Mar 2011
NCT02663024Unknown20Est. Jun 2020
Denali Therapeutics
Denali TherapeuticsCA - South SF
3 programs
tividenofusp alfaPHASE_1_21 trial
tividenofusp alfaPHASE_2_31 trial
tividenofusp alfaPHASE_2_31 trial
Active Trials
NCT04251026Active Not Recruiting47Est. Feb 2031
NCT06075537Enrolling By Invitation99Est. Jun 2027
NCT05371613Recruiting63Est. Dec 2027
Regenxbio
RegenxbioMD - Rockville
2 programs
Long-term Follow-UpN/A1 trial
Mucopolysaccharidosis Type II Natural HistoryN/A1 trial
Active Trials
NCT04597385Unknown12Est. Sep 2025
NCT03529786Completed36Est. Mar 2022
ViiV Healthcare
ViiV HealthcareNC - Durham
1 program
IdursulfaseN/A
GSK
GSKLONDON, United Kingdom
1 program
IdursulfaseN/A1 trial
Active Trials
NCT01602601Completed10Est. Jun 2012
Takeda
TakedaTOKYO, Japan
1 program
Iduronate-2-sulfatase enzyme replacement therapyPHASE_2_31 trial
Active Trials
NCT00069641Completed96Est. Mar 2005

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
JCR PharmaceuticalsJR-141
JCR PharmaceuticalsJR-141
Denali Therapeuticstividenofusp alfa
Denali Therapeuticstividenofusp alfa
JCR PharmaceuticalsJR-141
JCR PharmaceuticalsJR-141
TakedaIduronate-2-sulfatase enzyme replacement therapy
JCR PharmaceuticalsJR-141
JCR PharmaceuticalsJR-141
GC Biopharmaidursulfase beta
Denali Therapeuticstividenofusp alfa
Sangamo TherapeuticsSB-913
JCR PharmaceuticalsJR-141
GC BiopharmaGC1111_0.5mg/kg
Human BioScienceslymphocyte gene therapy

Showing 15 of 19 trials with date data

Clinical Trials (19)

Total enrollment: 709 patients across 19 trials

An Extension Study of JR-141 to Evaluate the Long-term Safety and Efficacy in MPS II (Hunter Syndrome) Subjects

Start: Feb 2023Est. completion: Feb 202880 patients
Phase 3Enrolling By Invitation

A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)

Start: Feb 2022Est. completion: Oct 202786 patients
Phase 3Active Not Recruiting

An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007

Start: Sep 2023Est. completion: Jun 202799 patients
Phase 2/3Enrolling By Invitation

A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)

Start: Jul 2022Est. completion: Dec 202763 patients
Phase 2/3Recruiting

An Extension Study of JR-141 in Patients With Mucopolysaccharidosis Type II

Start: Sep 2019Est. completion: Mar 203027 patients
Phase 2/3Active Not Recruiting

A Study of JR-141 in Patients With Mucopolysaccharidosis II

Start: Aug 2018Est. completion: Feb 202028 patients
Phase 2/3Completed
NCT00069641TakedaIduronate-2-sulfatase enzyme replacement therapy

Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II)

Start: Sep 2003Est. completion: Mar 200596 patients
Phase 2/3Completed

An Extension Study of JR-141-BR21 in Patients With Mucopolysaccharidosis II

Start: Jan 2019Est. completion: Dec 202719 patients
Phase 2Active Not Recruiting

A Study of JR-141 in Patients With Mucopolysaccharidosis II (BR21)

Start: Jul 2018Est. completion: Oct 201918 patients
Phase 2Completed
NCT02663024GC Biopharmaidursulfase beta

Study of Idursulfase-beta (GC1111) in Hunter Syndrome

Start: Dec 2016Est. completion: Jun 202020 patients
Phase 2Unknown

A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome

Start: Jul 2020Est. completion: Feb 203147 patients
Phase 1/2Active Not Recruiting

Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-913 in Subjects With MPS II

Start: May 2017Est. completion: May 20219 patients
Phase 1/2Terminated

A Study of JR-141 in Patients With Mucopolysaccharidosis Type II

Start: Mar 2017Est. completion: Oct 201714 patients
Phase 1/2Completed

To Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome Patients

Start: May 2010Est. completion: Mar 201131 patients
Phase 1/2Completed
NCT00004454Human BioScienceslymphocyte gene therapy

Phase I/II Study of Retroviral-Mediated Transfer of Iduronate-2-Sulfatase Gene Into Lymphocytes of Patients With Mucopolysaccharidosis II (Mild Hunter Syndrome)

Start: Oct 19962 patients
Phase 1/2Completed

A Study to Evaluate the Safety, Tolerability, PK and PD of Intracerebroventricular GC1123 in Patients with MPS Ⅱ

Start: Sep 2022Est. completion: Jun 202712 patients
Phase 1Active Not Recruiting
NCT04597385RegenxbioLong-term Follow-Up

Long-term Follow-Up for RGX-121

Start: Mar 2021Est. completion: Sep 202512 patients
N/AUnknown
NCT03529786RegenxbioMucopolysaccharidosis Type II Natural History

Mucopolysaccharidosis Type II Natural History

Start: Sep 2017Est. completion: Mar 202236 patients
N/ACompleted
NCT01602601GSKIdursulfase

A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723

Start: Apr 2012Est. completion: Jun 201210 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 709 patients
9 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.