25 completed, 2 recruiting, 1 active not recruiting, 1 not yet recruiting. 16 Phase 3, 13 Phase 1, 5 Phase 2, 1 Phase 4.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Compare GNR-139 and Eylea® in Patients With nAMD aflibercept, Eylea - nAMD | Phase 3 | Recruiting | AO GENERIUM | 180 | 2026-07-22 | 2026-09-30 |
| Reperfusion Approach in Predicted In-hospital Delay for Primary PCI in STEMI Single, weight-adjusted i.v. bolus of tenecteplase, catheterisation - STEMI - ST Elevation Myocardial Infarction | Phase 4 | Not yet recruiting | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation | 240 | 2026-05-20 | 2026-06-11 |
| A Study to Evaluate the Tolerability, Safety and Efficacy of GNR-097 Gene Therapy in Pediatric Patients With Duchenne Muscular Dystrophy GNR-097, Placebo followed by GNR-097 - Duchenne Muscular Dystrophy | Phase 1 / Phase 2 | Recruiting | AO GENERIUM | 32 | 2025-09-30 | 2026-06-29 |
| 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. GNR-127, 20 mcg, GNR-127, 40 mcg, GNR-127, 80 mcg - Rhinitis, Allergic, Seasonal | Phase 1 / Phase 2 | Completed | AO GENERIUM | 150 | 2024-10-07 | 2026-09-21 |
| A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers Complarate, Actemra® - Healthy Volunteers | Phase 1 | Completed | AO GENERIUM | 256 | 2024-06-20 | 2026-09-21 |
| An Efficacy and Safety Study of GNR-086 (Canakinumab Biosimilar) and Ilaris® in Patients With Adult-onset Still's Disease GNR-086, Ilaris® - Still's Disease Adult Onset | Phase 3 | Completed | AO GENERIUM | 118 | 2023-12-12 | 2025-08-17 |
| An Efficacy and Safety Study of GNR-068 (Ustekinumab Biosimilar) and Stelara® in the Treatment of Patients With Moderate to Severe Plaque Psoriasis GNR-068, Stelara® - Plaque Psoriasis | Phase 3 | Completed | AO GENERIUM | 422 | 2023-07-25 | 2026-09-21 |
| A Study of the Tolerance, Safety, and Pharmacokinetics of GNR-055 in Healthy Volunteers verenafusp alfa 6 mg/kg, verenafusp alfa 9 mg/kg, verenafusp alfa 12 mg/kg - Mucopolysaccharidosis Type II, Metabolic Diseases | Phase 1 | Completed | AO GENERIUM | 18 | 2023-04-06 | 2024-07-03 |
| Comparison of Complarate® (Tocilizumab Biosimilar) and Actemra® in Patients With Rheumatoid Arthritis Complarate®, Actemra® - Rheumatoid Arthritis | Phase 3 | Completed | AO GENERIUM | 465 | 2023-02-13 | 2024-07-03 |
| A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers Genolair, solution for subcutaneous administration, 150 mg, Genolair, lyophilisate for the preparation of solution for subcutaneous administration, Xolair®, solution for subcutaneous administration, 150 mg - Allergic Asthma | Phase 1 | Completed | AO GENERIUM | 180 | 2023-01-15 | 2024-07-10 |
| A Safety, Pharmacokinetics and Pharmacodynamics Study of GNR-086 and Ilaris® in Healthy Volunteers GNR-086, Ilaris® - Healthy Volunteers | Phase 1 | Completed | AO GENERIUM | 105 | 2022-09-06 | 2024-07-01 |
| A Safety and Pharmacokinetic Study of Complarate (Tocilizumab Biosimilar) and Actemra® in Healthy Volunteers Complarate®, Actemra® - Healthy Volunteers | Phase 1 | Completed | AO GENERIUM | 43 | 2022-04-11 | 2024-07-01 |
| Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients GNR-069 - Idiopathic Thrombocytopenic Purpura | Phase 3 | Completed | AO GENERIUM | 160 | 2022-03-28 | 2024-06-21 |
| Efficacy, Safety, pharmacokinetiсs, Immunogenicity of GNR-067 and Lucentis® GNR-067, Lucentis® - Age Related Macular Degeneration (ARMD) | Phase 3 | Unknown | AO GENERIUM | 408 | 2022-03-20 | 2023-09-13 |
| A Safety and Pharmacokinetics Study of Ustekinumab Biosimilar GNR-068 and Stelara® in Healthy Volunteers GNR-068, Stelara® - Healthy Volunteers | Phase 1 | Completed | AO GENERIUM | 122 | 2022-03-11 | 2024-07-01 |
| Efficacy and Safety of GNR-038 vs Berinert® in Patients With Hereditary Angioedema GNR-038, 50 МЕ/ kg, GNR-038, 100 МЕ/ kg, Berinert®, 20 МЕ/ kg - Hereditary Angioedema | Phase 2 / Phase 3 | Withdrawn | AO GENERIUM | 2021-12-01 | 2022-02-04 | |
| A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II GNR-055 1.0-2.0-3.0 mg/kg, GNR-055 2.0 mg/kg, GNR-055 3.0 mg/kg - Mucopolysaccharidosis Type II, Metabolic Diseases | Phase 2 / Phase 3 | Active not recruiting | AO GENERIUM | 32 | 2021-11-30 | 2026-09-21 |
| Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP GNR-069, Nplate - Idiopathic Thrombocytopenic Purpura | Phase 3 | Completed | AO GENERIUM | 160 | 2021-09-09 | 2024-03-06 |
| Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infarction GNR-060, Metalyse - ST Elevation Myocardial Infarction | Phase 3 | Completed | AO GENERIUM | 244 | 2021-09-03 | 2026-09-21 |
| GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL Cohort 1, GNR-084, Cohort 2, GNR-084, Cohort 3, GNR-084 - B-precursor Acute Lymphoblastic Leukemia, ALL | Phase 1 / Phase 2 | Terminated | AO GENERIUM | 14 | 2020-10-15 | 2026-09-21 |
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Immune System Diseases (7) · Genetic Diseases, Inborn (6) · Hypersensitivity (5) · Respiratory Tract Diseases (4) · Genetic Diseases, X-Linked (3) · Hematologic Diseases (3) · Hemoglobinuria, Paroxysmal (3) · Hemorrhage (3) · Lysosomal Storage Diseases (3) · Metabolic Diseases (3) · Mucopolysaccharidosis II (3) · Myocardial Infarction (3) · Neurobehavioral Manifestations (3) · Neurologic Manifestations (3) · Pathologic Processes (3)
eculizumab (4) · Omalizumab (3) · tocilizumab (3) · Ustekinumab (2) · canakinumab (2) · dornase alfa (2) · romiplostim (2) · Budesonide, Formoterol Fumarate Drug Combination (1) · Catheterization (1) · Complement C1 Inhibitor Protein (1) · Ranibizumab (1) · Single Person (1) · Solutions (1) · Standard of Care (1) · Tenecteplase (1)
Russia (32) · Belarus (1)
Oksana A. Markova, MD (18) · Oksana A. Markova, MD, MSc (4) · Oksana Markova, MD (3) · Oksana A Markova, MD (2) · Dmitry Pevzner, Doctor of Medical Sciences (1) · Oksana A. Markova, M.D. (1) · Rimma Gulyan (1)