porfimer

Trade name: photofrin

Small moleculeapprovedOrphan Drug FDA

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

Phase 1
8
Phase 2
17
Phase 3
6
Phase 4
1

Earliest trial started Sep 1, 1994 (NCT00004430)

Timeline

1980s

  1. Jun 6, 1989

    Orphan Drug Designation

1990s

  1. Jan 1, 1995

    Earliest Phase 2 Sponsor(trial)

  2. Dec 27, 1995

    Advanz Pharma — Earliest FDA Approval

  3. Dec 27, 1995

    Advanz Pharma — NDA Secondary Org

  4. Dec 27, 1995

    Advanz Pharma — NDA Organization

  5. Dec 27, 1995

    Pinnacle Biologics — Marketing Organization

  6. Dec 27, 1995

    Pinnacle Biologics — NDA Secondary Org

  7. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Aug 1, 2003

    Axcan — NDA Secondary Org

  2. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

  • DNAINHIBITOR

    DNA inhibitor

    Photodynamic therapy

Approval history

  • approvedPriority reviewDec 27, 1995

Chemistry & pharmacology

Loading structure…

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

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 IDPhaseStart dateSponsor(s)
NCT04836429Phase 1Nov 5, 2021State University of New York, Buffalo
NCT04753918Early Phase 1 (Phase 1)Mar 31, 2021Taoyan County Governmnet, Taiwan, Taoyuan General Hospital
NCT03735095Early Phase 1 (Phase 1)Jul 1, 2019National Cancer Institute (NCI), Pinnacle Biologics, State University of New York, Buffalo
NCT03727061Phase 2Jan 16, 2019National Cancer Institute (NCI), State University of New York, Buffalo
NCT03678350Phase 1Sep 30, 2018State University of New York, Buffalo
NCT03344861Phase 1Aug 14, 2017Advanz Pharma
NCT02916745Phase 4Jan 26, 2017Advanz Pharma
NCT02628665Phase 3Oct 1, 2015Henan Medical University
NCT01966809Phase 2Jun 1, 2015Medical College of Wisconsin, Pinnacle Biologics
NCT02106559N/ASep 1, 2014Ohio State University
NCT02082522Phase 3Aug 1, 2014Advanz Pharma, Cornell University
NCT02153229Phase 2May 1, 2014University of Pennsylvania
NCT02068157Phase 2Apr 1, 2014National Cancer Institute (NCI), State University of New York, Buffalo
NCT01770132Phase 1Apr 19, 2013American Society for Gastrointestinal Endoscopy, Indiana University, Pinnacle Biologics
NCT01682746Phase 1Mar 1, 2013Medical College of Wisconsin, Pinnacle Biologics
NCT01506115N/ASep 1, 2009Sungkyunkwan University
NCT00754910N/ADec 1, 2008National Cancer Institute (NCI), Ohio State University
NCT00513539Phase 3Jul 1, 2007University of London
NCT00253617Phase 3Nov 11, 2005National Cancer Institute (NCI), University of California, Los Angeles
NCT00118222Phase 3Mar 1, 2005Case Western Reserve University, National Cancer Institute (NCI)
Showing 20 of 30 trials
Page 1 / 2

Organizations

Research & Development (24)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
State University of New York, BuffaloAcademic/Hospital9931995
National Cancer Institute (NCI)Government8041999
Pinnacle BiologicsFor profit4022013
Advanz PharmaFor profit3332014
Cornell UniversityAcademic/Hospital2121999
Medical College of WisconsinAcademic/Hospital2222013
Ohio State UniversityAcademic/Hospital2212008
University of PennsylvaniaAcademic/Hospital2212004
American Society for Gastrointestinal EndoscopyAcademic/Hospital1012013
AxcanFor profit1012005
Case Western Reserve UniversityAcademic/Hospital1112005
Colorado Health FoundationAcademic/Hospital1111998
Department of Veteran AffairsGovernment1112005
Eastern Virginia Medical SchoolAcademic/Hospital1011994
Henan Medical UniversityAcademic/Hospital1112015
Indiana UniversityAcademic/Hospital1112013
Medical College of Hampton RoadsAcademic/Hospital1111994
North Florida Foundation for Research and EducationAcademic/Hospital1012005
Sungkyunkwan UniversityAcademic/Hospital1112009
Taoyan County Governmnet, TaiwanGovernment1012021
24 organizations
Page 1 / 2

Marketing (5)

OrganizationOrg typeRelationshipDate
Advanz PharmaFor profitNDA2Dec 27, 1995
Advanz PharmaFor profitNDADec 27, 1995
AxcanFor profitNDA2Aug 1, 2003
Pinnacle BiologicsFor profitMKTGDec 27, 1995
Pinnacle BiologicsFor profitNDA2Dec 27, 1995