Overview
The purified component of hematoporphyrin derivative, it consists of a mixture of oligomeric porphyrins. It is used in photodynamic therapy (hematoporphyrin photoradiation); to treat malignant lesions with visible light and experimentally as an antiviral agent. It is the first drug to be approved in the use of photodynamic therapy in the United States.
Background
The purified component of hematoporphyrin derivative, it consists of a mixture of oligomeric porphyrins. It is used in photodynamic therapy (hematoporphyrin photoradiation); to treat malignant lesions with visible light and experimentally as an antiviral agent. It is the first drug to be approved in the use of photodynamic therapy in the United States.
Indication
临床上用于对不能用手术及其他根治疗法的肺、子宫颈癌或需非手术治疗的患者，在内镜下能观察到病灶的全貌、可能进行激光照射的下列疾病：早期肺癌（0期或Ⅰ期）、浅表性食管癌、浅表性早期胃癌、宫颈癌初期及发育异常。
Associated Conditions
- Barrett's Esophagus
- Esophageal Cancer
- Completely obstructive Non-small cell lung cancer
- Microinvasive endobrachial Non-small cell lung cancer
- Partially obstructive Non-small cell lung cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/04/08 | Phase 1 | Suspended | |||
2021/02/15 | Early Phase 1 | UNKNOWN | Taoyuan General Hospital | ||
2018/11/08 | Phase 1 | Terminated | |||
2018/11/01 | Phase 1 | Terminated | |||
2018/09/19 | Phase 1 | Active, not recruiting | |||
2017/11/17 | Phase 1 | Completed | |||
2016/09/27 | Phase 1 | Completed | |||
2014/06/03 | Phase 2 | Active, not recruiting | |||
2014/04/08 | Not Applicable | Withdrawn | |||
2014/02/21 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Pinnacle Biologics, Inc. | 76128-155 | INTRAVENOUS | 75 mg in 31.8 mL | 8/15/2023 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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. | |||||