130 completed, 9 terminated, 4 withdrawn, 2 active not recruiting. 87 Phase 1, 36 Phase 3, 6 Not applicable, 6 Phase 4, 2 Phase 2.
By phase and status
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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 |
Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg and BREO ELLIPTA 100 mcg/25 mcg in Participants With Asthma Fluticasone furoate and vilanterol inhalation powder, Breo Ellipta, Placebo - Respiratory | Phase 3 | Withdrawn | Sandoz | | 2026-04-21 | 2026-05-12 |
Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis CYB704, Ocrevus-EU, Ocrevus-US - Relapsing Multiple Sclerosis | Phase 3 | Active not recruiting | Sandoz | 183 | 2025-06-10 | 2026-05-29 |
Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy® JPB898 (Induction and Maintenance), Opdivo-EU (Induction), Opdivo-US (Induction) - Melanoma | Phase 3 | Terminated | Sandoz | 52 | 2024-12-19 | 2026-02-24 |
Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold Acetylcysteine, Paracetamol, Phenylephrine - Common Cold | Phase 3 | Withdrawn | Sandoz | | 2024-09-20 | 2024-09-26 |
A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma GME751, Keytruda - EU, Keytruda - US - Melanoma | Phase 1 | Completed | Sandoz | 322 | 2024-05-15 | 2026-07-07 |
A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) GME751, Keytruda-EU - Metastatic NSCLC | Phase 3 | Completed | Sandoz | 218 | 2024-04-29 | 2026-04-09 |
Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis Mometasone + Azelastine, Mometasone Furoate, Azelastine Hydrochloride - Seasonal Allergic Rhinitis | Phase 1 | Terminated | Sandoz | 38 | 2023-06-08 | 2023-09-28 |
Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting Hyrimoz - Inflammatory Bowel Disease | | Active not recruiting | Sandoz | 562 | 2023-02-16 | 2026-01-12 |
Efficacy and Safety of Azelastine +Mometasone , Nasal Spray, 140 mcg + 50 mcg, (Sandoz d.d., Slovenia) and Momat Rino Advance, Nasal Spray, 140 mcg + 50 mcg, (Glenmark, India) Administered as a Monotherapy to Patients With Seasonal Allergic Rhinitis. Azelastine + Mometazone, nasal spray, Momat Rhino Advance - Seasonal Allergic Rhinitis | Phase 3 | Completed | Sandoz | 472 | 2023-02-13 | 2023-08-04 |
Study of the Efficacy and Safety of Broncho-munal®, Capsules, 7 mg for the Treatment of Acute Uncomplicated Respiratory Tract Infections Broncho-munal®, Placebo - Acute Uncomplicated Respiratory Tract Infections | Phase 3 | Completed | Sandoz | 556 | 2022-11-07 | 2023-08-04 |
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit SOK583A1 - Neovascular Age-related Macular Degeneration (nAMD) | Phase 3 | Completed | Sandoz | 36 | 2022-05-16 | 2023-05-10 |
A Crossover Bioequivalence Study of Olaparib Tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (Olaparib) Tablets 150 mg (AstraZeneca Pharmaceuticals LP), in Patients With Breast Cancer Gene (BRCA) Mutated Ovarian Cancer, Recurrent Ovarian Cancer or Metastatic Breast Cancer Olaparib tablets, 150 mg, Lynparza® (olaparib) tablets 150 mg - Ovarian Cancer, Breast Cancer | Phase 1 | Completed | Sandoz | 70 | 2022-04-07 | 2024-10-03 |
Prospective, Randomized, Multinational, Multicenter, Double-blind, Placebo and Active Controlled Trial in 4 Parallel-groups of Patients Suffering From Seasonal Allergic Rhinitis Mometasone, Azelastine, Placebo - Seasonal Allergic Rhinitis | Phase 3 | Completed | Sandoz | 669 | 2022-04-04 | 2023-07-11 |
Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe SOK583A1 (40 mg/mL), Prefilled Syringe (PFS) - Neovascular Age-related Macular Degeneration (nAMD) | Phase 3 | Completed | Sandoz | 30 | 2022-03-11 | 2022-11-18 |
Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration SOK583A1 (40 mg/mL), Eylea EU (40 mg/mL) - Neovascular Age-related Macular Degeneration | Phase 3 | Completed | Sandoz | 485 | 2021-05-12 | 2024-03-26 |
Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis acetylcysteine, Placebo - Rhinosinusitis | Phase 3 | Completed | Sandoz | 944 | 2020-10-22 | 2021-11-19 |
Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults. LRG-002, Placebo - Antibiotic-associated Diarrhea | Phase 3 | Completed | Sandoz | 520 | 2020-10-01 | 2022-03-14 |
An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine. Rotigotine TTS (Test), Neupro (Reference) - Parkinson Disease | Phase 1 | Terminated | Sandoz | 31 | 2019-12-03 | 2020-11-09 |
Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients. Advagraf®, Generic tacrolimus - Kidney Transplant | Phase 1 | Withdrawn | Sandoz | | 2019-09-02 | 2019-09-17 |
Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis GP2411, EU-Prolia (EU-authorized Prolia®) - Postmenopausal Women With Osteoporosis | Phase 3 | Completed | Sandoz | 527 | 2019-07-02 | 2023-03-08 |
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Conditions studied
Depression (13) · HIV Infections (10) · Hypertension (9) · Acquired Immunodeficiency Syndrome (7) · Anemia (7) · Renal Insufficiency, Chronic (7) · Arthritis, Rheumatoid (6) · Cytopenia (6) · Breast Neoplasms (5) · Hypersensitivity (5) · Neutropenia (5) · Rhinitis, Allergic, Seasonal (5) · Diabetes Mellitus, Type 2 (4) · Diarrhea (4) · Inflammation (4)
Interventions
Epoetin Alfa (5) · Suspensions (5) · Tablets (5) · sargramostim (5) · Cefdinir (4) · Cefprozil (4) · Desipramine (4) · Rituximab (4) · halofantrine (4) · pegfilgrastim (4) · Azithromycin (3) · Bupropion (3) · Diclofenac (3) · Fluoxetine (3) · Mometasone Furoate (3)
Countries
United States (32) · Germany (27) · Poland (19) · Russia (17) · Romania (16) · Spain (15) · Bulgaria (12) · France (12) · Hungary (11) · Austria (10) · Czechia (10) · Italy (10) · India (8) · United Kingdom (7) · Georgia (6)
Top investigators
Gaetano Morelli, M.D. (6) · Richard Larouche, M.D. (5) · So Ran Hong, M.D. (4) · Paul D. Larsen, M.D. (3) · Ronald Goldwater, M.D. (3) · Soran Hong, M.D. (3) · Ahmed Elshafeey, Ph.D. Pharma (2) · Andrea Vetter, Dr. (2) · Daryl G. Ficklin, D.O. (2) · Deepen Patel, M.D., CCFP (2) · Eric Masson, Pharm.D. (2)
Results publications
PMID 28637287, PMID 33651341, PMID 36791280, PMID 40279006, PMID 21590439, PMID 22732334, PMID 26122726, PMID 27020170, PMID 28637670, PMID 28689333, PMID 28712941, PMID 29084409, PMID 30295429, PMID 30361296, PMID 30487998, PMID 30836953, PMID 31138316, PMID 33119861, PMID 33178384, PMID 33263165, PMID 35287672, PMID 39545451, PMID 41709696
NIH funding
2018 (2), 2015 (1), 2019 (1), 2023 (1)