Drugs / Pentamidine isethionate

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) NEBUPENT — 1996-03-05 fda.gov ↗
Approved US (FDA) PENTAM — 1984-10-16 fda.gov ↗

Trials 8

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
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 Stop: Business
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 NCT00000991 ? → Apr 1994 HIV infectious disease, pneumocystosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 3 NCT00002340 — HIV infectious disease, pneumocystosis Glaxo Wellcome Completed No outcome recorded
Phase not applicable1 trial
— NCT00002053 — HIV infectious disease, pneumocystosis Fisons Completed No outcome recorded
Comparator or background therapy1 trial
Phase 3 NCT07463040 Comparator Jan 2027 → Mar 2029 expected cutaneous leishmaniasis Institute of Tropical Medicine, Belgium Not yet recruiting No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as Pentamidine isethionate ClinicalTrials.gov intervention name — accepted as the source's own label NCT00000974 ↗
6

NCT00002053 ↗

NCT07463040 ↗

NCT03403621 ↗

NCT00001996 ↗

NCT00002340 ↗

NCT00000991 ↗

Known as OCZ103-OS ClinicalTrials.gov intervention name — accepted as the source's own label NCT01378143 ↗
1

NCT01844791 ↗

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 ↗
Route Intravenous “intravenous pentamidine” NCT00000974 ↗