Overview
Tranilast is an antiallergic drug developed by Kissei Pharmaceuticals. In 1982, it was approved in Japan and South Korea for the management of bronchial asthma. Indications for keloid and hypertrophic scar were added in 1993. It has been used for the treatment of allergic disorders such as asthma, allergic rhinitis and atopic dermatitis.
Background
Tranilast is an antiallergic drug developed by Kissei Pharmaceuticals. In 1982, it was approved in Japan and South Korea for the management of bronchial asthma. Indications for keloid and hypertrophic scar were added in 1993. It has been used for the treatment of allergic disorders such as asthma, allergic rhinitis and atopic dermatitis.
Indication
For the treatment of bronchial asthma, keloid and hypertrophic scar, and allergic disorders such as asthma, allergic rhinitis and atopic dermatitis.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/14 | Early Phase 1 | Not yet recruiting | Yifeng Jing | ||
2024/10/16 | Phase 2 | Not yet recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2024/03/12 | Phase 4 | ENROLLING_BY_INVITATION | Second Affiliated Hospital of Xi'an Jiaotong University | ||
2022/11/25 | Phase 2 | Recruiting | Jian Guan | ||
2021/11/23 | Phase 4 | Completed | Wuhan Union Hospital, China | ||
2019/04/22 | Phase 2 | Recruiting | |||
2018/05/17 | Early Phase 1 | UNKNOWN | |||
2018/05/01 | Early Phase 1 | UNKNOWN | |||
2018/04/06 | Early Phase 1 | UNKNOWN | |||
2010/01/21 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tranilast Capsules | 国药准字H10920118 | 化学药品 | 胶囊剂 | 5/12/2020 | |
| Tranilast Capsules | 国药准字H10930175 | 化学药品 | 胶囊剂 | 5/19/2020 | |
| Tranilast Eye Drops | 国药准字H20110081 | 化学药品 | 眼用制剂 | 3/1/2021 | |
| Tranilast Granules | 国药准字H10980314 | 化学药品 | 颗粒剂 | 11/6/2019 | |
| Tranilast Tablets | 国药准字H10930209 | 化学药品 | 片剂 | 7/13/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||