Drugs / Pentamidine isethionate
Pentamidine isethionate
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | NEBUPENT | — | 1996-03-05 | fda.gov ↗ |
| Approved | US (FDA) | PENTAM | — | 1984-10-16 | fda.gov ↗ |
Trials 9 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03201159 | Jun 2017 → Feb 2018 | fatty liver disease | Gyongyi Szabo | Withdrawn | No outcome recorded |
| Phase 1 | NCT00000974 | ? → Sep 1996 | HIV infectious disease, pneumocystosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03403621 | Mar 2018 → Feb 2020 | reactive cutaneous fibrous lesion | Mayo Clinic | Terminated | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT01844791 | Sep 2012 → Jan 2014 | non-small cell lung carcinoma | Oncozyme Pharma Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01378143 | Mar 2011 → Mar 2014 | colorectal cancer | Oncozyme Pharma Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00001996 | — | HIV infectious disease, pneumocystosis | Glaxo Wellcome | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT00002340 | — | HIV infectious disease, pneumocystosis | Glaxo Wellcome | Completed | No outcome recorded |
| Phase 3 | NCT00000991 | ? → Apr 1994 | HIV infectious disease, pneumocystosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00002053 | — | HIV infectious disease, pneumocystosis | Fisons | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT07463040 Comparator | Jan 2027 → Mar 2029 expected | cutaneous leishmaniasis | Institute of Tropical Medicine, Belgium | Not yet recruiting | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pentamidine isethionate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00002053 ↗ |
| Known as | OCZ103-OS | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01378143 ↗ |
| Known as | PEN | “Aerosolized pentamidine (PEN) has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP.” NCT00000991 ↗ |
| Known as | Pentamidine | “Aerosolized pentamidine (PEN) has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP.” NCT00000991 ↗ |
| Known as | pentamidine bis(2-hydroxyethanesulfonate) | “OCZ103-OS [pentamidine bis(2-hydroxyethanesulfonate)], mFOLFOX6 or FOLFIRI” NCT01378143 ↗ |
| Known as | VLX103 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03201159 ↗ |
| Route | Intravenous | “intravenous pentamidine” NCT00000974 ↗ |