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Clinical-Stage Companies / AO GENERIUM

AO GENERIUM

Pre-Approval PRO BETA
🟡

Slowing Activity

No new clinical trials started in 1-2 years. Monitor for changes in pipeline strategy. Last trial started: 10/7/2024

23
Total Trials
13
Phase 3
3
Phase 2
4
Recruiting
249
Score

Pipeline by Phase

Phase 3
13
Phase 2
3
Phase 1
10

Therapeutic Focus

Healthy Volunteers Mucopolysaccharidosis Type II Metabolic Diseases Idiopathic Thrombocytopenic Purpura Hereditary Angioedema

Clinical Trials (23)

NCT07146360 Phase 3 COMPLETED

Efficacy and Safety Study of Proposed Biosimilar Product Reveliza vs Actilise in Patients With ST-segment Elevation Myocardial Infarction

Started: 5/25/2014

NCT06497491 Phase 3 COMPLETED

An Efficacy and Safety Study of GNR-086 (Canakinumab Biosimilar) and Ilaris® in Patients With Adult-onset Still's Disease

Started: 12/12/2023

NCT06488664 Phase 3 ACTIVE NOT RECRUITING

An Efficacy and Safety Study of GNR-068 (Ustekinumab Biosimilar) and Stelara® in the Treatment of Patients With Moderate to Severe Plaque Psoriasis

Started: 7/25/2023

NCT06475508 Phase 3 COMPLETED

Comparison of Complarate® (Tocilizumab Biosimilar) and Actemra® in Patients With Rheumatoid Arthritis

Started: 2/13/2023

NCT05492409 Phase 3 COMPLETED

Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients

Started: 3/28/2022

NCT05220878 Phase 3 COMPLETED

Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP

Started: 9/9/2021

NCT04463056 Phase 3 COMPLETED

Efficacy and Safety of Elizaria® vs. Soliris® in Patients With PNH

Started: 11/29/2017

NCT04679103 Phase 3 COMPLETED

A Safety and Immunogenicity Study in Long-term Treatment of Eculizumab (JSC "GENERIUM", Russian Federation)

Started: 5/3/2018

NCT04607629 Phase 3 COMPLETED

An Efficacy and Safety Study of Genolar® and Xolar® in the Persistent Atopic Bronchial Asthma

Started: 6/20/2018

NCT04459325 Phase 3 COMPLETED

Tigerase® Efficacy and Safety as Part of Complex Therapy in Patients With COVID-19

Started: 6/1/2020

NCT04468100 Phase 3 COMPLETED

Efficacy and Safety of Tigerase® vs. Pulmozyme® in Patients With Cystic Fibrosis

Started: 8/30/2017

NCT05208281 Phase 2 RECRUITING

A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II

Started: 11/30/2021

NCT04898309 Phase 2 WITHDRAWN

Efficacy and Safety of GNR-038 vs Berinert® in Patients With Hereditary Angioedema

Started: 12/1/2021

NCT07155499 Phase 1 ACTIVE NOT RECRUITING

A Clinical Trial for Evaluation of Efficacy, Safety and Immunogenicity of GNR-127 (Recombinant ABP Antigen Protein Which Carries a Birch Pollen Allergen [BET V 1] and an Apple Allergen [MAL D 1]) in Patients With Birch Pollen Allergic Rhinitis.

Started: 10/7/2024

NCT06488521 Phase 1 ACTIVE NOT RECRUITING

A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers

Started: 6/20/2024

NCT06494345 Phase 1 COMPLETED

A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers

Started: 1/15/2023

NCT06475404 Phase 1 COMPLETED

A Study of the Tolerance, Safety, and Pharmacokinetics of GNR-055 in Healthy Volunteers

Started: 4/6/2023

NCT06481215 Phase 1 COMPLETED

A Safety and Pharmacokinetics Study of Ustekinumab Biosimilar GNR-068 and Stelara® in Healthy Volunteers

Started: 3/11/2022

NCT06481202 Phase 1 COMPLETED

A Safety and Pharmacokinetic Study of Complarate (Tocilizumab Biosimilar) and Actemra® in Healthy Volunteers

Started: 4/11/2022

NCT06481189 Phase 1 COMPLETED

A Safety, Pharmacokinetics and Pharmacodynamics Study of GNR-086 and Ilaris® in Healthy Volunteers

Started: 9/6/2022

NCT04601389 Phase 1 COMPLETED

Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair®

Started: 4/18/2017

NCT04539340 Phase 1 COMPLETED

A Multi-cohort Study of the Tolerance, Safety, and Pharmacokinetics of GNR-055 in Healthy Volunteers

Started: 2/28/2020

NCT04557319 Phase 1 COMPLETED

Safety and Pharmacokinetics of GNR-038 in Healthy Volunteers

Started: 3/10/2020

Drug Candidates

GNR-127, 20 mcg GNR-127, 40 mcg GNR-127, 80 mcg GNR-127 placebo Revelise (GENERIUM, Russia) Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany) GNR-086 Ilaris® GNR-055 1.0-2.0-3.0 mg/kg GNR-055 2.0 mg/kg
Activity Status: Slowing
Last Trial Started: 10/7/2024
Last Trial Ended: 7/10/2025
Trials (12 months): 0
Completed Trials: 18
Data sourced from ClinicalTrials.gov. This company has no FDA-approved drugs.