Drugs / Cocaine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) GOPRELTO 2017-12-14 fda.gov

Trials 38 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 09 trials
Phase 0 NCT07086794 Nov 2025 → Feb 2028 expected substance-related disorder William Stoops Recruiting No outcome recorded
Phase 0 NCT05019430 Oct 2021 → Jan 2025 substance-related disorder William Stoops Completed No outcome recorded
Phase 0 NCT04296006 Jan 2021 → Feb 2025 substance-related disorder University of Kentucky Completed No outcome recorded
Phase 0 NCT03937986 Jul 2019 → Apr 2022 substance-related disorder William Stoops Completed No outcome recorded
Phase 0 NCT03954938 May 2019 → Dec 2021 substance-related disorder William Stoops Terminated No outcome recorded
Phase 0 NCT02383043 Feb 2015 → Apr 2018 substance-related disorder University of Kentucky Completed No outcome recorded
Phase 0 NCT02233647 Sep 2014 → Dec 2015 substance-related disorder William Stoops Completed No outcome recorded
Phase 0 NCT02141620 May 2014 → Apr 2016 cocaine abuse, cocaine dependence University of Kentucky Completed No outcome recorded
Phase 0 NCT01906346 Jan 2014 → Jun 2015 cocaine dependence University of Kentucky Completed No outcome recorded
Phase 117 trials
Phase 1 NCT06273540 Apr → Oct 2024 substance-related disorder Stalicla SA Completed No outcome recorded
Phase 1 NCT02563769 Oct 2016 → May 2018 cocaine abuse, cocaine dependence Temple University Completed No outcome recorded
Phase 1 NCT02856854 Jul 2016 → Feb 2017 substance-related disorder Embera NeuroTherapeutics, Inc. Completed No outcome recorded
Phase 1 NCT02775955 Feb → Jul 2016 Pharmaceutical Project Solutions, Inc. Completed No outcome recorded
Phase 1 NCT02775981 Feb → Jul 2016 drug allergy Pharmaceutical Project Solutions, Inc. Completed No outcome recorded
Phase 1 NCT02522325 Aug 2015 → Dec 2018 substance-related disorder William Stoops Completed No outcome recorded
Phase 1 NCT02537873 Jul 2015 → Jul 2018 substance-related disorder Virginia Commonwealth University Completed No outcome recorded
Phase 1 NCT02393599 May → Aug 2015 cocaine abuse National Institute on Drug Abuse (NIDA) Completed No outcome recorded
Phase 1 NCT02239913 Sep 2014 → Sep 2019 substance-related disorder University of Kentucky Completed No outcome recorded
Phase 1 NCT01978431 Nov 2012 → May 2014 cocaine dependence, impulse control disorder Yale University Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT05809453 Sep 2023 → Jun 2024 substance-related disorder University of Texas Southwestern Medical Center Completed No outcome recorded
Phase 1/2 NCT01137890 Jun 2010 → Mar 2012 cocaine dependence Johns Hopkins University Completed No outcome recorded
Phase 1/2 NCT00656357 Jun 2008 → May 2009 cocaine dependence Biotie Therapies Inc. Completed No outcome recorded
Phase 24 trials
Phase 2 NCT01846481 Apr → Jun 2013 cocaine dependence, opiate dependence Indivior Inc. Completed No outcome recorded
Phase 2 NCT01778010 Mar 2009 → Mar 2013 cocaine dependence New York State Psychiatric Institute Completed No outcome recorded
Phase 2 NCT00373581 Apr → Dec 2006 cocaine dependence New York State Psychiatric Institute Terminated No outcome recorded
Phase 2 NCT00373880 Apr 2005 → Aug 2008 cocaine abuse New York State Psychiatric Institute Completed No outcome recorded
Phase 32 trials
Phase 3 NCT04792034 Dec 2025 → Dec 2027 expected nasal cavity disorder Noden Pharma Recruiting No outcome recorded
Phase 3 NCT02500836 Sep 2015 → Jul 2016 nasal cavity disorder Lannett Company, Inc. Completed No outcome recorded
Phase 42 trials
Phase 4 NCT01706952 Dec 2012 → Dec 2013 chronic rhinosinusitis Marc Tewfik Completed No outcome recorded
Phase 4 NCT00000270 Dec 1995 substance-related disorder New York State Psychiatric Institute Withdrawn No outcome recorded
Phase not applicable1 trial
NCT00451230 Jun 2005 cocaine dependence National Institute on Drug Abuse (NIDA) Completed No outcome recorded
Also used as a comparator or background therapy in 11 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT03519022 Comparator Jun 2018 → May 2019 substance-related disorder Craig Rush Completed No outcome recorded
Phase 0 NCT01927640 Background Feb 2013 → Jan 2014 acute coronary syndrome, intermediate coronary syndrome Cedars-Sinai Medical Center Completed No outcome recorded
Phase 14 trials
Phase 1 NCT03471182 Comparator Feb 2018 → Aug 2022 cocaine dependence Yale University Completed No outcome recorded
Phase 1 NCT02538744 Comparator Aug 2015 → Aug 2018 cocaine dependence Baylor College of Medicine Completed No outcome recorded
Phase 1 NCT02302976 Background Nov 2014 → Aug 2018 cocaine dependence Yale University Completed No outcome recorded
Phase 1 NCT02018263 Comparator Oct 2013 → Jun 2014 cocaine dependence Yale University Completed No outcome recorded
Phase 33 trials
Phase 3 NCT06443255 Comparator Jul → Aug 2024 Rigshospitalet, Denmark Completed No outcome recorded
Phase 3 NCT02667054 Comparator Sep 2014 → Dec 2015 Pharmaceutical Project Solutions, Inc. Completed No outcome recorded
Phase 3 NCT01746940 Comparator Mar 2014 → Jul 2015 Lannett Company, Inc. Terminated No outcome recorded
Phase 41 trial
Phase 4 NCT05334017 Comparator Sep 2022 → Mar 2023 Rigshospitalet, Denmark Completed No outcome recorded
Phase not applicable1 trial
NCT01224847 Comparator Oct → Nov 2009 wet macular degeneration London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Completed No outcome recorded

Evidence & citations 22 cited values

Every value below carries the sentence it was read from. 50 sources stand behind the page.

FieldValueCited text
Known as Cocaine “RX0041-002 (Cocaine HCl, USP) is a crystalline, granular, or powder substance having a saline, slightly bitter taste that numbs tongue and lips.” NCT02775955
43

Cocaine is one of these appropriate drugs.” NCT06443255

NCT05019430

NCT01978431

NCT05334017

NCT01778010

NCT01927640

NCT00000270

NCT02302976

NCT04296006

NCT03954938

NCT05809453

NCT01906346

NCT02563769

NCT02383043

NCT02018263

NCT01846481

NCT02522325

NCT00373880

NCT07086794

NCT02537873

NCT01746940

NCT02500836

NCT02141620

NCT01706952

NCT03519022

NCT02393599

NCT03471182

NCT02538744

NCT02239913

NCT00094315

NCT00000316

NCT01851473

NCT01224847

NCT06273540

NCT00000315

NCT01978457

NCT02233647

NCT00000290

NCT00373581

NCT00656357

NCT03937986

NCT00451230

NCT02856854

Known as (r)-(-)-cocaine ChEMBL registry synonym — accepted as the source's own label CHEMBL370805
Known as Benzoylmethylecgonine ChEMBL registry synonym — accepted as the source's own label CHEMBL370805
Known as Cocaine hcl ChEMBL registry synonym — accepted as the source's own label CHEMBL370805
Known as Cocaine HCl, USP “RX0041-002 (Cocaine HCl, USP) is a crystalline, granular, or powder substance having a saline, slightly bitter taste that numbs tongue and lips.” NCT02775955
Known as cocaine hydrochloride “Cocaine (cocaine hydrochloride 4% nasal solution) will be administered (3 mg/kg) intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise.” NCT05809453
6

“Drug: cocaine hydrochlorideNCT01978457

“Drug: Cocaine hydrochlorideNCT02018263

“Drug: cocaine hydrochlorideNCT02302976

NCT00338546

NCT01137890

NCT04792034

Known as Cocaine hydrochloride cii ChEMBL registry synonym — accepted as the source's own label CHEMBL370805
Known as Cocaine muriate ChEMBL registry synonym — accepted as the source's own label CHEMBL370805
Known as Cocainum ChEMBL registry synonym — accepted as the source's own label CHEMBL370805
Known as Cocainum muriaticum ChEMBL registry synonym — accepted as the source's own label CHEMBL370805
Known as Goprelto ChEMBL registry synonym — accepted as the source's own label CHEMBL370805
Known as IDS-NC-004 ChEMBL registry synonym — accepted as the source's own label CHEMBL370805
Known as MCV 4526 ChEMBL registry synonym — accepted as the source's own label CHEMBL370805
Known as Neurocaine ChEMBL registry synonym — accepted as the source's own label CHEMBL370805
Known as NIH 8211 ChEMBL registry synonym — accepted as the source's own label CHEMBL370805
Known as NSC-25263 ChEMBL registry synonym — accepted as the source's own label CHEMBL370805
Known as Numbrino ChEMBL registry synonym — accepted as the source's own label CHEMBL370805
Known as RX0041 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02667054
Known as RX0041-002 RX0041-002 (Cocaine HCl, USP) is a crystalline, granular, or powder substance having a saline, slightly bitter taste that numbs tongue and lips.” NCT02775955
1

NCT02775981

Action Inhibit “Cocaine blocks sodium channel activity” NCT02775955
Modality Small molecule CHEMBL370805
Route Intravenous “cocaine (32mg /70kg iv)” NCT00000290