Drugs / Cocaine
Cocaine
also known as
cocaine hydrochloride · RX0041-002 · (r)-(-)-cocaine · Benzoylmethylecgonine · Cocaine hcl · Cocaine HCl, USP · Cocaine hydrochloride cii · Cocaine muriate · +10 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | GOPRELTO | — | 2017-12-14 | fda.gov ↗ |
| Filed | US (FDA) | Numbrino | — | 2017-12-01 | “New Drug Application (NDA) for Cocaine Hydrochloride (HCl) Topical Solution, 4% and 10%, with a proposed trade name of Numbrino™, has been accepted for filing” investorroom.com ↗ |
| Filed | US (FDA) | — | — | 2017-09-25 | “has filed a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Cocaine Hydrochloride (HCl) Topical Solution” investorroom.com ↗ |
Trials 38
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 | NCT02775981 | Feb → Jul 2016 | drug allergy | Pharmaceutical Project Solutions, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02775955 | Feb → Jul 2016 | — | 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 | NCT01851473 | Oct 2012 → Oct 2015 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT01978457 | Oct 2012 → Dec 2019 | cocaine dependence | Yale University | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT00094315 | Sep 2004 → Jul 2005 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Unknown | No outcome recorded |
| Phase 1 | NCT00000290 | May 1997 → Dec 2001 | cocaine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT00000315 | Nov 1996 → Dec 2001 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT00000316 | Aug 1996 → Dec 2001 | cocaine abuse | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT00338546 | — | cocaine intoxication | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded |
| Phase 1/23 trials · 1 missed | ||||||
| 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 | Missed primary |
| 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 Stop: Business |
| Phase 2 | NCT00373880 | Apr 2005 → Aug 2008 | cocaine abuse | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| 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 | Met primary |
| Phase 42 trials · 1 missed | ||||||
| Phase 4 | NCT01706952 | Dec 2012 → Dec 2013 | chronic rhinosinusitis | Marc Tewfik | Completed | Missed primary |
| Phase 4 | NCT00000270 | Dec 1995 | substance-related disorder | New York State Psychiatric Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase not applicable1 trial | ||||||
| — | NCT00451230 | Jun 2005 | cocaine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Comparator or background therapy11 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 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 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 4 | NCT05334017 Comparator | Sep 2022 → Mar 2023 | — | Rigshospitalet, Denmark | Completed | No outcome recorded |
| — | 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 |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2020-01-13 | Lannett Company, Inc. | Regulatory Lannett Announces FDA Approval Of NDA For Branded Anesthetic Product, Cocaine Hydrochloride Nasal Solution 4% investorroom.com ↗
Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA), submitted under the 505(b)(2) regulatory pathway, for Cocaine Hydrochloride (HCl) Nasal Solution 4% (40 mg/mL), the company's branded local anesthetic product. |
| 2019-07-03 | Lannett Company, Inc. | Regulatory FDA Clears Path For The Continuing Review Of Lannett Company's New Drug Application investorroom.com ↗
We are pleased with the FDA's decision, which affirmed our belief that the regulatory review of our NDA can continue, |
| 2017-12-01 | Lannett Company, Inc. | Regulatory Lannett Announces FDA Acceptance Of 505(b)(2) New Drug Application For Cocaine Hydrochloride Topical Solution, A Proprietary Anesthetic Product investorroom.com ↗ |
| 2017-09-25 | Lannett Company, Inc. | Regulatory Lannett's Board Of Directors Initiates CEO Search investorroom.com ↗
The company also announced that it has filed a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Cocaine Hydrochloride (HCl) Topical Solution, the company's proprietary local anesthetic product. |
| 2016-10-27 | Lannett Company, Inc. | Results LANNETT ANNOUNCES SUCCESSFUL PHASE III CLINICAL TRIAL RESULTS FOR PROPRIETARY C-TOPICAL® PRODUCT investorroom.com ↗
The 646-patient study met all primary clinical endpoints of the trial and had a statistically significant treatment effect for both the 4% and the 10% solutions. |
| 2012-01-04 | Lannett Company, Inc. | Regulatory Lannett reaches special protocol assessment agreement with fda For cocaine hcl phase iii trial Lannett reaches special protocol assessment agreement with fda For cocaine hcl phase iii trial investorroom.com ↗
Lannett Company, Inc. (NYSE AMEX: LCI) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA), regarding the design of a Phase III study of the company’s Cocaine HCl topical solution product, C-Topical™. |
All press releases naming this drug 8 releases
Evidence & citations 22 cited values
Every value below carries the sentence it was read from. 50 sources stand behind the page.
| Field | Value | Cited 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 ↗ |
| 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 hydrochloride” NCT02302976 ↗ “Drug: Cocaine hydrochloride” NCT02018263 ↗ “Drug: cocaine hydrochloride” NCT01978457 ↗ |
| 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 ↗ |
| Action | Inhibit | “Cocaine blocks sodium channel activity” NCT02775955 ↗ |
| Modality | Small molecule | — CHEMBL370805 ↗ |
| Route | Intravenous | “cocaine (32mg /70kg iv)” NCT00000290 ↗ |