porfimer
Trade name: photofrin
Approved
Dec 27, 1995
Porfimer is a photosensitizing agent used in the photodynamic therapy (PDT) of tumors. Porfimer sodium was approved under the brand name PHOTOFRIN for the palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy. For the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC). For the treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated. In addition, for the ablation of high-grade dysplasia in Barrett’s esophagus patients who do not undergo esophagectomy. The cytotoxic and antitumor actions of PHOTOFRIN® are light and oxygen dependent. Photodynamic therapy with Porfimer sodium is a two-stage process. The first stage is the intravenous injection of the drug, which mainly is concentrated in the tumor tissues for a longer period. Illumination with 630 nm wavelength laser light constitutes the second stage of therapy. Cellular damage is a consequence of the propagation of radical reactions. Radical initiation may occur after porfimer absorbs light to form a porphyrin excited state. Tumor death also occurs through ischemic necrosis secondary to vascular occlusion that appears to be partly mediated by thromboxane A2 release. The laser treatment induces a photochemical, not a thermal, effect. The necrotic reaction and associated inflammatory responses may evolve over several days. — NCATS
Clinical trial activity
30 trials · 24 clinical orgs · 3 marketing orgs
Earliest trial started Sep 1, 1994 (NCT00004430)
Timeline
1980s
- Jun 6, 1989
Orphan Drug Designation
1990s
- Jan 1, 1995
Earliest Phase 2 Sponsor(trial)
- Dec 27, 1995
Advanz Pharma — Earliest FDA Approval
- Dec 27, 1995
Advanz Pharma — NDA Secondary Org
- Dec 27, 1995
Advanz Pharma — NDA Organization
- Dec 27, 1995
Pinnacle Biologics — Marketing Organization
- Dec 27, 1995
Pinnacle Biologics — NDA Secondary Org
- Jan 1, 1998
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Studied for
- Bile Duct Neoplasms · Phase 3
- Brain Neoplasms · Phase 3
- Carcinoma, Non-Small-Cell Lung · Phase 4
- Carcinoma, Squamous Cell · Phase 2
- Carcinoma, Verrucous · Phase 2
- Esophageal Neoplasms · Phase 3
- Gallbladder Neoplasms · Phase 3
- Head and Neck Neoplasms · Phase 2
- Klatskin Tumor · Phase 3
- Liver Neoplasms · Phase 2
- Lung Neoplasms · Phase 4
- Mesothelioma · Phase 2
- Mesothelioma, Malignant · Phase 2
- Neoplasms · Phase 2
- Pancreatic Neoplasms · Phase 2
- Pleura · Phase 1
- Precancerous Conditions · Phase 2
- Small Cell Lung Carcinoma · Early Phase 1
- Squamous Cell Carcinoma of Head and Neck · Phase 2
- Tongue Neoplasms · Phase 2
- Urinary Bladder Neoplasms · Phase 1/Phase 2
Mechanism of action
- DNAINHIBITOR
DNA inhibitor
Photodynamic therapy
Approval history
- approvedPriority reviewDec 27, 1995
Chemistry & pharmacology
SMILES
CCc1c(C)c2cc3nc(cc4nc(cc5C=C(C)c(cc1[nH]2)[nH]5)c(C)c4CCC(=O)O)c(CCC(=O)O)c3C- Mol. weight
- 538.65 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- Yes
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaPorfimer sodium ↗
- NCATSM15H03K69B ↗
- ChEMBLCHEMBL594426 ↗
- ChEMBLCHEMBL1201481 ↗
Also known as
- cl-184116
- dihematoporphyrin
- dihematoporphyrin
- photofrin
- photofrin
- photofrin
- photofrin
- photofrin
- porfimer
- porfimer
- porfimer
- porfimer
- porfimère sodique
- porfimère sodique
- porfimer natrium
- porfimer sodico
- porfimer sodico
- porfimer sodium
- porfimer sodium
- porfimer sodium
- porfimer sodium
- porfimer sodium
- porfimer sodium
- porfimer sodium
- porfimer sodium
- porfimer sodium
- porfimerum natricum
- porfimerum natricum
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04836429 | Phase 1 | Nov 5, 2021 | State University of New York, Buffalo |
| NCT04753918 | Early Phase 1 (Phase 1) | Mar 31, 2021 | Taoyan County Governmnet, Taiwan, Taoyuan General Hospital |
| NCT03735095 | Early Phase 1 (Phase 1) | Jul 1, 2019 | National Cancer Institute (NCI), Pinnacle Biologics, State University of New York, Buffalo |
| NCT03727061 | Phase 2 | Jan 16, 2019 | National Cancer Institute (NCI), State University of New York, Buffalo |
| NCT03678350 | Phase 1 | Sep 30, 2018 | State University of New York, Buffalo |
| NCT03344861 | Phase 1 | Aug 14, 2017 | Advanz Pharma |
| NCT02916745 | Phase 4 | Jan 26, 2017 | Advanz Pharma |
| NCT02628665 | Phase 3 | Oct 1, 2015 | Henan Medical University |
| NCT01966809 | Phase 2 | Jun 1, 2015 | Medical College of Wisconsin, Pinnacle Biologics |
| NCT02106559 | N/A | Sep 1, 2014 | Ohio State University |
| NCT02082522 | Phase 3 | Aug 1, 2014 | Advanz Pharma, Cornell University |
| NCT02153229 | Phase 2 | May 1, 2014 | University of Pennsylvania |
| NCT02068157 | Phase 2 | Apr 1, 2014 | National Cancer Institute (NCI), State University of New York, Buffalo |
| NCT01770132 | Phase 1 | Apr 19, 2013 | American Society for Gastrointestinal Endoscopy, Indiana University, Pinnacle Biologics |
| NCT01682746 | Phase 1 | Mar 1, 2013 | Medical College of Wisconsin, Pinnacle Biologics |
| NCT01506115 | N/A | Sep 1, 2009 | Sungkyunkwan University |
| NCT00754910 | N/A | Dec 1, 2008 | National Cancer Institute (NCI), Ohio State University |
| NCT00513539 | Phase 3 | Jul 1, 2007 | University of London |
| NCT00253617 | Phase 3 | Nov 11, 2005 | National Cancer Institute (NCI), University of California, Los Angeles |
| NCT00118222 | Phase 3 | Mar 1, 2005 | Case Western Reserve University, National Cancer Institute (NCI) |
Organizations
Research & Development (24)
Marketing (5)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Advanz Pharma | For profit | NDA2 | Dec 27, 1995 |
| Advanz Pharma | For profit | NDA | Dec 27, 1995 |
| Axcan | For profit | NDA2 | Aug 1, 2003 |
| Pinnacle Biologics | For profit | MKTG | Dec 27, 1995 |
| Pinnacle Biologics | For profit | NDA2 | Dec 27, 1995 |