Clinical Trials
Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate Tranilast across conditions including nasopharyngeal carcinoma, active rheumatoid arthritis, pterygium, allergic conjunctivitis, rosacea, hyperuricemia, and post-percutaneous coronary intervention inflammatory markers. Sponsored by academic medical centers (Nanfang Hospital, Xi'an Jiaotong University, Tongji Medical College, Imperial College London) and industry entities (Nuon Therapeutics, Alcon Research), these studies report recruiting, completed, and withdrawn statuses. Key Phase 2 and Phase 3 investigations assess Tranilast as a radiosensitizer in resistant nasopharyngeal carcinoma and for treating active rheumatoid arthritis and pterygium excision.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06643689 | NOT_YET_RECRUITING | Esophageal Stricture; Esophageal Neoplasms |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2025-01-01 | PHASE2 |
| NCT06689514 | RECRUITING | Prostatic Hypertrophy, Benign |
Yifeng Jing |
2025-01-20 | EARLY_PHASE1 |
| NCT05626829 | UNKNOWN | Nasopharyngeal Carcinoma; Recurrent Cancer |
Jian Guan |
2022-07-20 | PHASE2 |
| NCT06307288 | UNKNOWN | Rosacea |
Second Affiliated Hospital of Xi'an Jiaotong University |
2023-10-16 | PHASE4 |
| NCT03923140 | UNKNOWN | Cryopyrin-Associated Periodic Syndromes |
Peking Union Medical College Hospital |
2019-05-23 | PHASE2 |
| NCT05130892 | COMPLETED | NLRP3; hsCRP; Percutaneous Coronary Intervention |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
2021-11-15 | PHASE4 |
| NCT05626829 | Recruiting | Nasopharyngeal Carcinoma|Recurrent Cancer |
Jian Guan|Nanfang Hospital Southern Medical University |
2022-07-20 | Phase 2 |
| NCT03490708 | UNKNOWN | Mucinoses |
The First Affiliated Hospital with Nanjing Medical University |
2018-04 | EARLY_PHASE1 |
| NCT03512873 | UNKNOWN | Scleredema Adultorum |
The First Affiliated Hospital with Nanjing Medical University |
2018-06 | EARLY_PHASE1 |
| NCT03528070 | UNKNOWN | Sarcoidosis |
The First Affiliated Hospital with Nanjing Medical University |
2018-05 | EARLY_PHASE1 |
| NCT01003613 | COMPLETED | Pterygium |
Gildasio Castello de Almeida Junior |
2009-02 | PHASE3 |
| NCT01109121 | COMPLETED | Moderate to Severe Gout; Hyperuricemia |
Nuon Therapeutics, Inc. |
2010-06 | PHASE2 |
| NCT00882024 | COMPLETED | Active Rheumatoid Arthritis |
Nuon Therapeutics, Inc. |
2009-03 | PHASE2 |
| NCT01052987 | COMPLETED | Gout; Hyperuricemia |
Nuon Therapeutics, Inc. |
2010-01 | PHASE2 |
| NCT00995618 | COMPLETED | Gout; Hyperuricemia |
Nuon Therapeutics, Inc. |
2009-09 | PHASE2 |
| NCT00717808 | WITHDRAWN | Rheumatoid Arthritis |
Imperial College London |
2008-09 | PHASE1 |
| NCT00882024 | Completed | Active Rheumatoid Arthritis |
Nuon Therapeutics Inc. |
2009-03 | Phase 2 |
| NCT01003613 | Completed | Pterygium |
Gildasio Castello de Almeida Junior|Hospital de Base|Sao Jose do Rio Preto Medical School |
2009-02 | Phase 3 |
| NCT00717808 | Withdrawn | Rheumatoid Arthritis |
Imperial College London|Nuon Therapeutics Inc. |
2008-09 | Phase 1 |
| NCT00818805 | COMPLETED | Allergic Conjunctivitis |
Alcon Research |
2008-07 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2024-11-14)
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).