GOPRELTO (cocaine hydrochloride)
GOPRELTO is indicated for the treatment of Local Anesthesia.
Details
- Status
- Prescription
- First Approved
- 2017-12-14
- Patent Cliff
- 2037
- Routes
- NASAL
- Dosage Forms
- SOLUTION
GOPRELTO Approval History
What GOPRELTO Treats
1 indicationsGOPRELTO is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Local Anesthesia
GOPRELTO Boxed Warning
ABUSE AND DEPENDENCE CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence [see Warning and Precautions (5.1) . ] WARNING: ABUSE AND DEPENDENCE See full prescribing information for complete boxed warning. CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence. (5.1)...
WARNING: ABUSE AND DEPENDENCE CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence [see Warning and Precautions (5.1) . ] WARNING: ABUSE AND DEPENDENCE See full prescribing information for complete boxed warning. CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence. (5.1)
GOPRELTO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to GOPRELTO
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06273540 | STA-P7-C001 C-043-2023 | Ph 1 | completed | Phase1, STP7 Cocaine Drug-Drug Interaction Study |
| NCT02302976 | 1409014655 1R21DA040914-01A1 | Ph 1 | completed | GLP-1 Agonism for Blocking Cocaine Euphoria and Self-Administration |
| NCT01978431 | 1001006250 R25MH071584 | Ph 1 | completed | Impulsivity and Stimulant Administration |
| NCT02018263 | 1212011268 | Ph 1 | completed | Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans |
| NCT01978457 | 1104008404 | Ph 1 | terminated | Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction |
| NCT01137890 results posted | R01DA027065 R01DA027065 | Ph 1, Ph 2 | completed | Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GOPRELTO FDA Label Details
Indications & Usage
FDA Label (PDF)GOPRELTO is indicated for the treatment of Local Anesthesia.
WARNING: ABUSE AND DEPENDENCE CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence [see Warning and Precautions (5.1) . ] WARNING: ABUSE AND DEPENDENCE See full prescribing information for complete boxed warning. CNS stimulants, including cocaine hydrochlor...
GOPRELTO Patents & Exclusivity
Patents (12 active)
Pro Intelligence Preview
Deep insights for GOPRELTO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 15 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 4 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.