Overview
Pentoxifylline (PTX) is a synthetic dimethylxanthine derivative that modulates the rheological properties of blood and also has both anti-oxidant and anti-inflammatory properties. Although originally developed to treat intermittent claudication, a form of exertion-induced leg pain common in patients with peripheral arterial disease, PTX has been investigated for its possible use in diverse conditions, including osteoradionecrosis, diabetic kidney disease, and generally any condition associated with fibrosis. More recently, PTX has been suggested as a possible treatment for COVID-19-induced pulmonary complications due to its ability to regulate the production of inflammatory cytokines. Pentoxifylline has been marketed in Europe since 1972; PTX extended-release tablets sold under the trade name TRENTAL by US Pharm Holdings were first approved by the FDA on Aug 30, 1984, but have since been discontinued. A branded product, PENTOXIL, marketed by Upsher-Smith Laboratories, and generic forms marketed by Valeant Pharmaceuticals and APOTEX have been available since the late 1990s.
Background
Pentoxifylline (PTX) is a synthetic dimethylxanthine derivative that modulates the rheological properties of blood and also has both anti-oxidant and anti-inflammatory properties. Although originally developed to treat intermittent claudication, a form of exertion-induced leg pain common in patients with peripheral arterial disease, PTX has been investigated for its possible use in diverse conditions, including osteoradionecrosis, diabetic kidney disease, and generally any condition associated with fibrosis. More recently, PTX has been suggested as a possible treatment for COVID-19-induced pulmonary complications due to its ability to regulate the production of inflammatory cytokines. Pentoxifylline has been marketed in Europe since 1972; PTX extended-release tablets sold under the trade name TRENTAL by US Pharm Holdings were first approved by the FDA on Aug 30, 1984, but have since been discontinued. A branded product, PENTOXIL, marketed by Upsher-Smith Laboratories, and generic forms marketed by Valeant Pharmaceuticals and APOTEX have been available since the late 1990s.
Indication
Pentoxifylline is indicated for the treatment of intermittent claudication in patients with chronic occlusive arterial disease. Pentoxifylline may improve limb function and reduce symptoms but cannot replace other therapies such as surgical bypass or removal of vascular obstructions.
Associated Conditions
- Intermittent Claudication
- Venous Leg Ulcer (VLU)
- Severe alcoholic liver disease
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/31 | Phase 2 | Not yet recruiting | |||
2025/04/25 | Phase 3 | Completed | |||
2025/04/06 | Phase 2 | Not yet recruiting | |||
2025/04/01 | Phase 1 | Not yet recruiting | |||
2025/03/25 | Phase 4 | Not yet recruiting | Centro de Atencion e Investigacion Medica | ||
2024/10/09 | Phase 2 | Not yet recruiting | |||
2024/08/20 | Not Applicable | Completed | |||
2024/07/10 | Phase 2 | Not yet recruiting | |||
2024/06/13 | Not Applicable | Completed | |||
2024/05/20 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | 67544-252 | ORAL | 400 mg in 1 1 | 6/25/2014 | |
| REMEDYREPACK INC. | 70518-1285 | ORAL | 400 mg in 1 1 | 1/31/2024 | |
| Aidarex Pharmaceuticals LLC | 33261-992 | ORAL | 400 mg in 1 1 | 1/23/2014 | |
| Oceanside Pharmaceuticals | 68682-101 | ORAL | 400 mg in 1 1 | 11/1/2019 | |
| Direct_Rx | 72189-025 | ORAL | 400 mg in 1 1 | 8/2/2019 | |
| Physicians Total Care, Inc. | 54868-4515 | ORAL | 400 mg in 1 1 | 9/14/2012 | |
| Direct_Rx | 72189-025 | ORAL | 400 mg in 1 1 | 8/2/2019 | |
| State of Florida DOH Central Pharmacy | 53808-0758 | ORAL | 400 mg in 1 1 | 5/31/2010 | |
| STAT RX USA LLC | 16590-856 | ORAL | 400 mg in 1 1 | 4/26/2011 | |
| State of Florida DOH Central Pharmacy | 53808-0757 | ORAL | 400 mg in 1 1 | 5/31/2010 |
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 |
|---|---|---|---|---|---|
| TRENLIN 400 SR TABLET 400 mg | SIN10727P | TABLET, FILM COATED | 400 mg | 2/8/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Pentoxifylline and Glucose Injection | 国药准字H20020099 | 化学药品 | 注射剂 | 12/15/2023 | |
| Pentoxifylline and Glucose Injection | 国药准字H20030274 | 化学药品 | 注射剂(注射液) | 8/24/2020 | |
| Pentoxifylline and Glucose Injection | 国药准字H20010226 | 化学药品 | 注射剂 | 7/16/2022 | |
| Pentoxifylline Enteric-coated Tablets | 国药准字H20194048 | 化学药品 | 片剂 | 5/16/2024 | |
| Pentoxifylline Enteric-coated Tablets | 国药准字H61021836 | 化学药品 | 片剂 | 12/11/2020 | |
| Pentoxifylline Enteric-coated Tablets | 国药准字H31021926 | 化学药品 | 片剂(肠溶) | 3/19/2020 | |
| Pentoxifylline Enteric-coated Tablets | 国药准字H33020730 | 化学药品 | 片剂 | 4/30/2020 | |
| Pentoxifylline Enteric-coated Tablets | 国药准字H23022035 | 化学药品 | 片剂(肠溶) | 7/27/2020 | |
| Pentoxifylline Enteric-coated Tablets | 国药准字H13023191 | 化学药品 | 片剂 | 3/27/2020 | |
| Pentoxifylline Enteric-coated Tablets | 国药准字H10973009 | 化学药品 | 片剂(肠溶) | 11/22/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TRENLIN 400 SR TAB 400MG | N/A | pharmalink healthcare ltd | N/A | N/A | 4/27/1999 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TRENTAL 400 pentoxifylline (oxpentifylline) 400 mg modified release tablet blister pack | 81197 | Medicine | A | 12/14/2001 |