Pipeline
Orphan diseases
GNR-097
Duchenne muscular dystrophy (INN: gene therapy)
Drug(s):
GNR-097
Status:
Ongoing
Start:
February 24, 2025
End:
March 31, 2030
Protocol No:
GNR097-DMD01
RCT No:
96, February 24, 2025
Type:
MMCT
Patients:
42
Therapeutic areas:
Other; Neurology; Pediatrics
Dosage form:
Concentrate for infusion solution, 20 mg/ml
Protocol Title:
Multicenter, single-blind, randomized, placebo-controlled study of a single intravenous administration of the gene therapy drug GNR-097 in pediatric patients with progressive Duchenne muscular dystrophy
Developer:
JSC GENERIUM
Country:
Russia
CRO:
Joint Stock Company GENERIUM, 601125, Vladimir Region, Petushinsky District, Volginsky Settlement, Zavodskaya Street, Building 273, Russia
Study Objective:
To evaluate the tolerability, safety, and efficacy of the gene therapy drug GNR-097 after a single intravenous administration to pediatric patients with DMD.
GNR-104
Hypophosphatasia (INN: asfotase alfa)
GNR-105
Morquio syndrome, Mucopolysaccharidosis type IV (INN: elosulfase alfa)
GNR-118
Paroxysmal nocturnal hemoglobinuria (INN: ravulizumab)
Autoimmune diseases
GNR-093
Multiple sclerosis (INN: natalizumab)
Drug(s):
Natalizumab (GNR-093)
Status:
Ongoing
Start:
January 01, 2024
End:
December 31, 2026
Protocol No:
NTZ-MS-III
RCT No:
755, December 28, 2023
Type:
Clinical Trial
Patients:
330
Therapeutic areas:
Neurology
Dosage form:
Concentrate for infusion solution, 20 mg/ml
Protocol Title:
A multicenter, double-blind, randomized, comparative study of the efficacy, safety, and immunogenicity of GNR-093 (GENERIUM JSC, Russia) and Tysabri® (Biogen Idec Limited, UK), conducted in parallel groups in patients with highly active forms of multiple sclerosis
Developer:
JSC GENERIUM
Country:
Russia
CRO:
Joint Stock Company GENERIUM, 601125, Vladimir Region, Petushinsky District, Volginsky Settlement, Zavodskaya Street, Building 273, Russia
Study Objective:
To evaluate the efficacy, safety, and immunogenicity of GNR-093 and Tysabri® in patients with highly active multiple sclerosis
GNR-085
Multiple sclerosis (INN: ocrelizumab)
Drug(s):
GNR-085
Status:
Ongoing
Start:
December 17, 2025
End:
September 30, 2027
Protocol No:
GNR085-MS03
RCT No:
571, December 17, 2025
Type:
MMCT
Patients:
130
Therapeutic areas:
Neurology
Dosage form:
Concentrate for infusion solution, 30 mg/ml
Protocol Title:
An international, multicenter, double-blind, randomized, comparative study of the efficacy, safety, and immunogenicity of GNR-085 (GENERIUM, Russia) and Ocrevus® (F. Hoffmann-La Roche Ltd., Switzerland) in parallel groups in patients with relapsed multiple sclerosis.
Developer:
JSC GENERIUM
Country:
Russia
CRO:
Joint Stock Company GENERIUM, 601125, Vladimir Region, Petushinsky District, Volginsky Settlement, Zavodskaya Street, Building 273, Russia
Study Objective:
To conduct a comparative evaluation of the efficacy, safety, and immunogenicity of GNR-085 (JSC GENERIUM, Russia) and Ocrevus® (F. Hoffmann-La Roche Ltd., Switzerland) Ocrevus® (F. Hoffmann-La Roche Ltd., Switzerland) in patients with RSO.
Oncology
GNR-107
Metastatic colorectal cancer (INN: panitumumab)
Allergology
GNR-127
Allergen immunotherapy
Drug(s):
GNR-127 (Recombinant adsorbed vaccine for the prevention of birch pollen allergy)
Status:
Ongoing
Start:
October 02, 2025
End:
May 31, 2028
Protocol No:
GNR127-BET03
RCT No:
448, October 2, 2025
Type:
Clinical Trial
Patients:
1,305
Therapeutic areas:
Allergology
Dosage form:
Suspension for subcutaneous administration, 0.5 ml/dose
Protocol Title:
Double-blind, randomized, placebo-controlled study of the efficacy, safety, and immunogenicity of GNR-127 in patients with allergic rhinitis (AR) sensitized to birch pollen
Developer:
JSC "GENERIUM"
Country:
Russia
CRO:
Joint Stock Company GENERIUM, 601125, Vladimir Region, Petushinsky District, Volginsky Settlement, Zavodskaya Street, Building 273, Russia
Study Objective:
To evaluate the results of GNR-127 and placebo in patients with AR sensitized to birch pollen.