11 completed, 4 unknown, 3 not yet recruiting, 1 active not recruiting. 13 Phase 1, 3 Phase 3, 2 Phase 4, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 13 | Completed 7, Not yet recruiting 3, Unknown 2, Active not recruiting 1 |
| Phase 3 | 3 | Completed 2, Unknown 1 |
| Phase 4 | 2 | Completed 1, Unknown 1 |
| Phase 2 | 1 | Completed 1 |
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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 |
|---|---|---|---|---|---|---|
| Bioequivalence Study of AJU-C715 and C715R in Healthy Adult Volunteers Test Drug, Reference Drug - Hypercholerolemia, Dyslipidemia | Phase 1 | Completed | AJU Pharm Co., Ltd. | 61 | 2026-08-06 | 2026-09-09 |
| Bioequivalence Study of AJU-G721 and G721R in Healthy Adult Volunteers Under Fed Conditions Test Drug, Reference Drug - Moderate-to-severe Benign Prostatic Hyperplasia (BPH) | Phase 1 | Not yet recruiting | AJU Pharm Co., Ltd. | 36 | 2026-07-01 | 2026-06-11 |
| Bioequivalence Study of AJU-G721 and G721R in Healthy Adult Volunteers Under Fasting Conditions Test Drug, Reference Drug - Moderate-to-severe Benign Prostatic Hyperplasia (BPH) | Phase 1 | Completed | AJU Pharm Co., Ltd. | 45 | 2026-06-27 | 2026-09-21 |
| To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R in Healthy Adults Test Drug, Reference Drug - Hypercholesterolemia, Dyslipidemia | Phase 1 | Completed | AJU Pharm Co., Ltd. | 41 | 2026-06-11 | 2026-07-10 |
| Bioequivalence Study of AJU-R713 and R713R in Healthy Adult Volunteers AJU-R713, R713R - Bronchial Asthma, Perennial Allergic Rhinitis | Phase 1 | Completed | AJU Pharm Co., Ltd. | 62 | 2025-12-12 | 2026-09-18 |
| A Study to Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults Comparator 1, Comparator 2, Test Drug - Type2 Diabetes Mellitus | Phase 1 | Not yet recruiting | AJU Pharm Co., Ltd. | 50 | 2025-08-01 | 2025-06-24 |
| A Study to Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults: Fed State Study Comparator 1, Comparator 2, Test Drug - Type2 Diabetes Mellitus | Phase 1 | Not yet recruiting | AJU Pharm Co., Ltd. | 32 | 2025-08-01 | 2025-07-01 |
| To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C714 and C714R in Healthy Adults Test Drug, Reference Drug - Dyslipidemia | Phase 1 | Active not recruiting | AJU Pharm Co., Ltd. | 60 | 2025-05-24 | 2025-06-12 |
| To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C711 in Healthy Adults Test Drug, Reference Drug - Hypercholesterolemia | Phase 1 | Completed | AJU Pharm Co., Ltd. | 60 | 2025-03-29 | 2025-06-12 |
| The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome OM-89 [Uro-Vaxom® Capsule], OM-89 Placebo [Uro-Vaxom® Capsule Placebo] - Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Prostatitis | Phase 4 | Unknown | AJU Pharm Co., Ltd. | 332 | 2023-12-20 | 2024-04-04 |
| Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients AJU-S56 5%, Placebo Group(Vehicle) - Dry Eye Syndromes | Phase 3 | Unknown | AJU Pharm Co., Ltd. | 396 | 2023-11-10 | 2024-04-08 |
| Efficacy and Safety of AJU-C52 in Essential Hypertension Patients AJU-C52L, AJU-C52, C52R1L, C52R1M - Essential Hypertension | Phase 3 | Completed | AJU Pharm Co., Ltd. | 193 | 2022-10-18 | 2026-09-21 |
| To Evaluate the Efficacy and Safety of Combination Therapy With B55R1 and B55R2 Compared to B55R1 Monotherapy in Patients With NPDR B55R1 and B55R2, B55R1 and placebo for B55R2 - Non-Proliferative Diabetic Retinopathy | Phase 4 | Completed | AJU Pharm Co., Ltd. | 53 | 2022-04-28 | 2026-09-04 |
| Efficacy and Safety of AJU-S56 in Dry Eye Syndrome Patients (AJU-S56 5% and placebo), AJU-S56 5%, Placebo(Vehicle) - Dry Eye Syndromes | Phase 2 | Completed | AJU Pharm Co., Ltd. | 99 | 2021-11-22 | 2024-04-29 |
| A Clinical Trial to Evaluate the Safety and Pharmacokinetics of AJU-C52L in Healthy Volunteers C52R1H Tab. and C52R2 Tab., AJU-C52L - Hypertension | Phase 1 | Unknown | AJU Pharm Co., Ltd. | 60 | 2021-09-24 | 2021-10-14 |
| A Clinical Trial to Evaluate the Safety and Pharmacokinetics of AJU-C52H in Healthy Volunteers C52R1M Tab. and C52R2 Tab., AJU-C52H - Hypertension | Phase 1 | Unknown | AJU Pharm Co., Ltd. | 60 | 2021-09-17 | 2021-10-14 |
| Efficacy and Safety of AJU-A51 in Type 2 Diabetes Mellitus Patients AJU-A51, A51R2, A51R3 - Type2 Diabetes | Phase 3 | Completed | AJU Pharm Co., Ltd. | 235 | 2021-04-27 | 2024-03-26 |
| Evaluation of Pharmacokinetics and Safety of AJU-A51 in Healthy Adults AJU-A51 Tab., A51R1 Tab. and A51R2 Tab. - Diabetes Mellitus, Type 2 | Phase 1 | Completed | AJU Pharm Co., Ltd. | 48 | 2020-08-01 | 2021-07-22 |
| The Drug-drug Interaction Study of AJU-A51R1 and AJU-A51R2 Treatment A, Treatment B, Treatment C - T2DM (Type 2 Diabetes Mellitus) | Phase 1 | Completed | AJU Pharm Co., Ltd. | 30 | 2020-07-02 | 2021-07-21 |
Dyslipidemias (3) · Diabetes Mellitus, Type 2 (2) · Dry Eye Syndromes (2) · Hypercholesterolemia (2) · Hypertension (2) · Asthma (1) · Essential Hypertension (1) · Prostatitis (1) · Rhinitis, Allergic, Perennial (1)
Drug Evaluation (11) · Control Groups (1) · OM 89 (1)
South Korea (19)
Jang Hee Hong (1) · Min-gul Kim (1)