Drugs / IVOSPEMIN

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed US (FDA) — — —

“ネブライザーで投与する長時間作用性抗コリン薬(LAMA)SUN-101/eFlowⓇ(グリコピロニウム臭 化物)は、今年7月にFDAへ新薬申請をいたしました。” nxera.life ↗

Trials 7

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT03412799 Jun 2018 → Feb 2022 pancreatic ductal adenocarcinoma Panbela Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT02657330 Jan 2016 → Oct 2017 pancreatic ductal adenocarcinoma Panbela Therapeutics, Inc. Completed No outcome recorded
Phase 21 trial · 1 met primary
Phase 2 NCT02038829 Jan → May 2014 chronic obstructive pulmonary disease Sunovion Respiratory Development Inc. Completed Met primary
Phase 2/31 trial
Phase 2/3 NCT05254171 Aug 2022 → Aug 2026 overdue pancreatic ductal adenocarcinoma Panbela Therapeutics, Inc. Recruiting No outcome recorded
Phase 33 trials · 2 met primary
Phase 3 NCT02347774 Feb → Dec 2015 chronic obstructive pulmonary disease Sunovion Respiratory Development Inc. Completed Met primary
Phase 3 NCT02347761 Feb → Nov 2015 chronic obstructive pulmonary disease Sunovion Respiratory Development Inc. Completed Met primary
Phase 3 NCT02276222 Oct 2014 → Feb 2016 chronic obstructive pulmonary disease Sunovion Respiratory Development Inc. Completed No outcome recorded

Evidence & citations 9 cited values

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

FieldValueCited text
Known as IVOSPEMIN ChEMBL registry synonym — accepted as the source's own label CHEMBL80386 ↗
Known as IVOSPEMIN HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL80386 ↗
Known as Ivospemin tetrahydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL80386 ↗
Known as Longhala Magnair “Longhala™ Magnair™ (glycopyrrolate) Inhalation Solution, a drug/device combination of the long-acting antimuscarinic glycopyrrolate administered using the eFlow® closed system...” PMID 30584583 ↗ Jun 2018
Known as SBP-101 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05254171 ↗
2

NCT03412799 ↗

NCT02657330 ↗

Known as SBP-101 TETRAHYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL80386 ↗
Known as SUN-101 “SUN-101 3 mcg bid” NCT02038829 ↗
3

NCT02347761 ↗

NCT02347774 ↗

NCT02276222 ↗

Modality Other / unclassified “a drug/device combination of the long-acting antimuscarinic glycopyrrolate administered using the eFlow® closed system (eFlow CS) nebulizer” PMID 30584583 ↗ Jun 2018
Route Inhaled “via eFlow Closed System (CS) nebulizer” NCT02276222 ↗