Drugs / Butorphanol

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (3) US (FDA) STADOL 1982-02-26 – 2009-03-13 fda.gov
Approved US (FDA) STADOL 1978-08-22 fda.gov

Trials 14 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT03429179 Mar 2018 → Feb 2019 Shengjing Hospital Completed No outcome recorded
Phase 2 NCT03810391 Dec 2017 → Dec 2018 Shengjing Hospital Completed No outcome recorded
Phase 46 trials
Phase 4 NCT05024799 Jan 2022 → Dec 2024 respiratory failure The Affiliated Hospital of Qingdao University Unknown No outcome recorded
Phase 4 NCT04477733 Aug 2020 → Sep 2021 Beijing Tiantan Hospital Completed No outcome recorded
Phase 4 NCT04315935 Dec 2019 → Dec 2020 pain agnosia Jiangsu Hengrui Pharmaceutical Co., Ltd. Unknown No outcome recorded
Phase 4 NCT00795314 Nov 2008 → Jul 2009 Nanjing Medical University Completed No outcome recorded
Phase 4 NCT00519246 Feb → Dec 2007 neuropathy, painful Nanjing Medical University Completed No outcome recorded
Phase 4 NCT00510666 Jan → May 2007 Nanjing Medical University Completed No outcome recorded
Phase not applicable6 trials
NCT06031129 Mar → Jul 2023 liver and intrahepatic bile duct neoplasm Bibo Wang Completed No outcome recorded
NCT06524596 Jan → Dec 2022 Wuhan Children's Hospital Completed No outcome recorded
NCT05201560 Jan 2022 → Jan 2023 nosocomial infection Shanghai Zhongshan Hospital Unknown No outcome recorded
NCT04490980 Aug → Nov 2020 Tongji Hospital Unknown No outcome recorded
NCT04295109 Mar → Jul 2020 adenomyosis, endometrial cancer, leiomyoma, uterine cervix neoplasm The First Affiliated Hospital with Nanjing Medical University Unknown No outcome recorded
NCT03398759 Feb 2018 → Dec 2020 RenJi Hospital Unknown No outcome recorded
Also used as a comparator or background therapy in 6 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 44 trials
Phase 4 NCT06398834 Background Mar 2022 → Oct 2023 Second People's Hospital of Hefei City Completed No outcome recorded
Phase 4 NCT04436224 Comparator Sep 2020 → Jun 2022 Nanfang Hospital, Southern Medical University Unknown No outcome recorded
Phase 4 NCT03065530 Comparator Feb → Sep 2017 The First Affiliated Hospital with Nanjing Medical University Completed No outcome recorded
Phase 4 NCT00738192 Comparator Jul 2008 → Mar 2009 Nanjing Medical University Completed No outcome recorded
Phase not applicable2 trials
NCT07478692 Background Jun → Oct 2025 Qing Yuan Completed No outcome recorded
NCT02043366 Comparator Feb 2014 → Jun 2015 Tianjin Medical University General Hospital Completed No outcome recorded

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 22 sources stand behind the page.

FieldValueCited text
Known as Butorphanol “This study aimed to investigate the effect of the equivalent doses of fentanyl, oxycodone, and butorphanol on bowel function in patients undergoing laparoscopic hysterectomy.” PMID 35209847 Feb 2022
19

“Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.” NCT03065530

Butorphanol tartrate 1 mg i.v.” NCT00519246

NCT04315935

NCT07478692

NCT04490980

NCT03810391

NCT00795314

NCT00510666

NCT05201560

NCT06524596

NCT03429179

NCT02043366

NCT06031129

NCT05024799

NCT00738192

NCT04436224

NCT03398759

NCT06398834

NCT04477733

Known as Butorfanol ChEMBL registry synonym — accepted as the source's own label CHEMBL33986
Known as Butorphanol Tartrate “Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.” NCT03065530
3

Butorphanol tartrate 1 mg i.v.” NCT00519246

“Drug: Butorphanol TartrateNCT00795314

“Drug: Butorphanol tartrateNCT00510666

Known as Butorphanol tartrate civ ChEMBL registry synonym — accepted as the source's own label CHEMBL33986
Known as Butorphanol tartrate preservative free ChEMBL registry synonym — accepted as the source's own label CHEMBL33986
Known as Dolorex ChEMBL registry synonym — accepted as the source's own label CHEMBL33986
Known as LEVO-BC-2627 ChEMBL registry synonym — accepted as the source's own label CHEMBL33986
Known as LEVO-BC-2627 TARTRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL33986
Known as Moradol ChEMBL registry synonym — accepted as the source's own label CHEMBL33986
Known as Stadol ChEMBL registry synonym — accepted as the source's own label CHEMBL33986
Known as Stadol ns ChEMBL registry synonym — accepted as the source's own label CHEMBL33986
Known as Stadol preservative free ChEMBL registry synonym — accepted as the source's own label CHEMBL33986
Known as Torbugesic ChEMBL registry synonym — accepted as the source's own label CHEMBL33986
Known as Torbutrol ChEMBL registry synonym — accepted as the source's own label CHEMBL33986
Action Activate “butorphanol has both spinal analgesic and sedative functions because of predominantly central κ-receptor agonist activation” NCT02043366
2

“Kappa opioid receptor partial agonist” CHEMBL33986

“Mu opioid receptor partial agonist” CHEMBL33986

Modality Other / unclassified “Butorphanol is a mixed agonist-antagonist opioid” NCT03398759
Route Intravenous “patients received an intravenous loading dose of 10 microg kg(-1) butorphanol followed by infusion of 2 microg kg(-1) h(-1) butorphanol” PMID 19122548 Jan 2009
Target OPRK1 “Kappa opioid receptor partial agonist” CHEMBL33986
Target OPRM1 “Mu opioid receptor partial agonist” CHEMBL33986