15 completed, 1 not yet recruiting, 1 terminated. 8 Phase 1, 6 Phase 2, 2 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 8 | Completed 6, Not yet recruiting 1, Terminated 1 |
| Phase 2 | 6 | Completed 6 |
| Phase 3 | 2 | Completed 2 |
| Phase 4 | 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 |
|---|---|---|---|---|---|---|
| A Phase 1 Study of ISM4808 in Healthy Adult Subjects ISM4808, Placebo - Healthy Volunteers | Phase 1 | Not yet recruiting | TaiGen Biotechnology Co., Ltd. | 86 | 2026-02-13 | 2026-02-17 |
| To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection TG-1000 - Influenza Virus Infection | Phase 2 | Completed | TaiGen Biotechnology Co., Ltd. | 202 | 2020-12-15 | 2022-03-09 |
| To Evaluate the Safety, Tolerability, and Pharmacokinetics Profiles of TG-1000 in Healthy Volunteers, and the Food Effect on Pharmacokinetics of Single Oral Dose of TG-1000 in Healthy Volunteers. TG-1000, Placebo - Healthy Chinese Volunteers | Phase 1 | Completed | TaiGen Biotechnology Co., Ltd. | 66 | 2020-07-17 | 2021-01-07 |
| Oral Nemonoxacin in Treating Elderly Patients With CAP Nemonoxacin - Community-acquired Pneumonia | Phase 4 | Completed | TaiGen Biotechnology Co., Ltd. | 100 | 2018-09-11 | 2021-11-24 |
| Pilot Study of Mobilization and Treatment of Disseminated Tumor Cells in Men With Metastatic Prostate Cancer Burixafor Hydrobromide, Docetaxel, G-CSF - Prostate Cancer | Phase 1 | Terminated | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 3 | 2016-07-01 | 2019-01-18 |
| Evaluate the Efficacy and Safety of TG-2349 in Subjects With Hepatitis C Infection TG-2349, Ribavirin, Interferon Alfa-2a - Hepatitis C, Chronic | Phase 2 | Completed | TaiGen Biotechnology Co., Ltd. | 25 | 2015-05-01 | 2023-07-14 |
| A Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin in Treating CAP Nemonoxacin, Levofloxacin - Community-acquired Pneumonia | Phase 3 | Completed | TaiGen Biotechnology Co., Ltd. | 598 | 2014-06-01 | 2021-10-25 |
| Study to Evaluate the PK, Relative Bioavailability and Safety of TG-2349 With Single Oral Dose Under Fed Condition in Healthy Volunteers TG-2349 as the original formulation, TG-2349 as a new capsule formulation - Healthy | Phase 1 | Completed | TaiGen Biotechnology Co., Ltd. | 24 | 2014-04-01 | 2014-12-19 |
| Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride Nemonoxacin 500 mg, Nemonoxacin 650 mg, Moxifloxacin 400 mg - Pneumonia | Phase 2 | Completed | TaiGen Biotechnology Co., Ltd. | 207 | 2013-03-01 | 2025-07-01 |
| A Study Evaluating the Effect of a Single-dose Oral Administration of Nemonoxacin Capsule on QTc Intervals and Heart Rhythms of Healthy Subjects and the Influence of Food Intake on QTc Intervals and Pharmacokinetic Characteristics Nemonoxacin 500Mg Capsule, Moxifloxacin 400Mg Tablet, Nemonoxacin 750Mg Capsule - Healthy Volunteers | Phase 1 | Completed | TaiGen Biotechnology Co., Ltd. | 48 | 2012-06-25 | 2017-12-06 |
| A Study to Evaluate the Safety, Tolerability, and PK in Healthy Volunteers and HCV Genotype 1 Infected Patients TG-2349, placebo - Healthy, Hepatitis C, Chronic | Phase 1 | Completed | TaiGen Biotechnology Co., Ltd. | 135 | 2011-10-01 | 2014-12-19 |
| Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP Levofloxacin, Nemonoxacin - Pneumonia | Phase 3 | Completed | TaiGen Biotechnology Co., Ltd. | 540 | 2011-04-01 | 2013-06-18 |
| Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP) Levofloxacin 500 mg placebol, Nemonoxacin 3 tablets - Community-acquired Pneumonia | Phase 2 | Completed | TaiGen Biotechnology Co., Ltd. | 192 | 2009-08-01 | 2018-01-24 |
| A Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion Nemonoxacin Malate Sodium Chloride - Healthy | Phase 1 | Completed | TaiGen Biotechnology Co., Ltd. | 176 | 2008-09-01 | 2012-02-20 |
| Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections TG-873870 (Nemonoxacin) - Diabetic Foot Infections | Phase 2 | Completed | TaiGen Biotechnology Co., Ltd. | 40 | 2008-06-01 | 2025-07-01 |
| Clinical Study on Oral Nemonoxacin Malate Capsules Nemonoxacin - Healthy Volunteers | Phase 1 | Completed | TaiGen Biotechnology Co., Ltd. | 76 | 2008-01-01 | 2011-07-15 |
| Safety and Efficacy Comparison of TG-873870(Nemonoxacin) to Levofloxacin in Community-Acquired Pneumonia TG-873870(Nemonoxacin) - Community-Acquired Pneumonia | Phase 2 | Completed | TaiGen Biotechnology Co., Ltd. | 264 | 2006-12-01 | 2009-11-25 |
Community-Acquired Pneumonia (4) · Hepatitis C, Chronic (2) · Pneumonia (2) · Prostatic Neoplasms (1)
nemonoxacin (8) · Levofloxacin (3) · Moxifloxacin (2) · Docetaxel (1) · Dosage Forms (1) · Granulocyte Colony-Stimulating Factor (1) · Interferon alpha-2 (1) · Ribavirin (1) · Tablets (1)
China (8) · Taiwan (7) · United States (4) · South Africa (2) · Thailand (1)
Yingyuan Zhang, PhD (3) · Nicole Sims, DO (2) · AJ Bester, Doctor (1) · Andre Tudhope, M.D. (1) · CT de Villiers, Doctor (1) · Che-Han Hsu, M.D. (1) · Chieh-Feng Chen, M.D. (1) · Chien-Wen Chou, M.D. (1) · DJ Jansen van Rensburg, Doctor (1) · Dirkie van Rensburg, M.D. (1) · E van Nieuwenhuizen, Doctor (1) · G Nieuwoudt, Doctor (1) · Gan Zhou (1) · Horng-Chyuan Lin, Doctor (1)
PMID 22650326, PMID 25092690, PMID 25534726, PMID 26748734, PMID 29803534, PMID 30181096