Overview
Nintedanib is a small molecule kinase inhibitor used in the treatment of pulmonary fibrosis, systemic sclerosis-associated interstitial lung disease, and non-small cell lung cancer (NSCLC). It was first approved for use in the United States in 2014. Within the spectrum of idiopathic pulmonary fibrosis treatment options, nintedanib is currently one of only two disease-modifying therapies available and indicated for the condition (the other being Pirfenidone) and as such is used as a first-line treatment following diagnosis to slow down the progressive loss of lung function. As a chemotherapeutic agent for NSCLC, nintedanib, in combination with Docetaxel, is reserved for patients who have tried and failed first-line chemotherapeutic options.
Indication
Nintedanib is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) and to slow declining pulmonary function in patients with systemic sclerosis-associated interstitial lung disease. It is also indicated for the treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype. In the EU, under the brand name Vargatef, nintedanib is indicated in combination with docetaxel for the treatment of adult patients with metastatic, locally advanced, or locally recurrent non-small cell lung cancer of adenocarcinoma histology who have already tried first-line therapy.
Associated Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Respiratory Function Impaired
- Chronic Progressive Fibrosing Interstitial Lung Disease
- Locally advanced Non-Small Cell Lung Carcinoma (NSCLC)
- Locally recurrent Non-Small Cell Lung Carcinoma (NSCLC)
- Metastatic Non-Small Cell Lung Carcinoma (NSCLC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/11 | Phase 1 | Not yet recruiting | |||
2024/12/04 | Phase 1 | Not yet recruiting | |||
2024/07/08 | Phase 2 | Not yet recruiting | |||
2024/10/03 | Phase 1 | Completed | |||
2024/08/26 | N/A | Recruiting | Second Hospital of Shanxi Medical University | ||
2024/08/23 | Phase 1 | Completed | |||
2024/07/03 | N/A | Active, not recruiting | |||
2024/06/28 | Phase 4 | Recruiting | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2024/03/06 | Phase 3 | Not yet recruiting | National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland | ||
2023/10/06 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0143 | ORAL | 100 mg in 1 1 | 10/31/2022 | |
| Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0145 | ORAL | 150 mg in 1 1 | 10/31/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/14/2015 | ||
Authorised | 4/19/2024 | ||
Authorised | 11/21/2014 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| OFEV SOFT CAPSULES 100MG | SIN14921P | CAPSULE, LIQUID FILLED | 100mg | 1/14/2016 | |
| OFEV SOFT CAPSULES 150MG | SIN14922P | CAPSULE, LIQUID FILLED | 150mg | 1/14/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Nintedanib Esilate Soft Capsules | 国药准字H20233583 | 化学药品 | 胶囊剂 | 5/19/2023 | |
| Nintedanib Esilate Soft Capsules | 国药准字H20234164 | 化学药品 | 胶囊剂 | 9/12/2023 | |
| Nintedanib Esilate Soft Capsules | 国药准字H20234074 | 化学药品 | 胶囊剂 | 8/29/2023 | |
| Nintedanib Esilate Soft Capsules | 国药准字H20243030 | 化学药品 | 胶囊剂 | 1/9/2024 | |
| Nintedanib Esilate Soft Capsules | 国药准字H20234073 | 化学药品 | 胶囊剂 | 8/29/2023 | |
| Nintedanib Esilate Soft Capsules | 国药准字HJ20170354 | 化学药品 | 胶囊剂 | 5/6/2022 | |
| Nintedanib Esilate Soft Capsules | 国药准字H20234165 | 化学药品 | 胶囊剂 | 9/12/2023 | |
| Nintedanib Esilate Soft Capsules | 国药准字H20243031 | 化学药品 | 胶囊剂 | 1/9/2024 | |
| Nintedanib Esilate Soft Capsules | 国药准字H20233841 | 化学药品 | 胶囊剂 | 6/30/2023 | |
| Nintedanib Esilate Soft Capsules | 国药准字H20233842 | 化学药品 | 胶囊剂 | 6/30/2023 |
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 |
|---|---|---|---|---|---|
| OFEV nintedanib (as esilate) 150 mg soft capsule blister pack | 226068 | Medicine | A | 9/1/2015 | |
| VARGATEF nintedanib (as esilate) 150 mg soft capsule blister pack | 226066 | Medicine | A | 9/1/2015 | |
| OFEV nintedanib (as esilate) 100 mg soft capsule blister pack | 226065 | Medicine | A | 9/1/2015 | |
| VARGATEF nintedanib (as esilate) 100 mg soft capsule blister pack | 226067 | Medicine | A | 9/1/2015 |
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