FDA · United States
phentermine hydrochloride — FDA regulatory status
phentermine hydrochloride (PHENTERMINE HYDROCHLORIDE) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- PHENTERMINE HYDROCHLORIDE
- Originator
- United Therapeutics Europe Ltd
- Mechanism
- Norepinephrine transporter releasing agent
- Target
- Sodium-dependent noradrenaline transporter
- Structured fields
- 8
Sponsor / originator context: United Therapeutics Europe Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Norepinephrine transporter releasing agent. Target: Sodium-dependent noradrenaline transporter. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 97 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| DTX401 | Phase 3 | Ultragenyx UK | NCT05139316 |
| RANOLAZINE, FLECARDIA Διάλυμα για ένεση/έχχυση | Phase 3 | Anaxis Pharma | 2024-514677-22-00 |
| Tora-Dol /ml soluzione iniettabile for Patients scheduled for major su… | Phase 3 | Telethon Foundation | 2024-515333-14-00 |
| Acido Acetilsalicilico Teva Italia compresse... | Phase 2 | Telethon Foundation | 2024-515333-14-03 |
| CAPTURE | Phase 2 | Telethon Foundation | 2024-519568-42-00 |
| Enpatoran Placebo, Enpatoran | Phase 2 | MSD Merck Sharp | 2024-510871-39-00 |
| Enpatoran low dose | Phase 2 | Serana Europe | NCT05162586 |
| MATRIx | Phase 2 | Telethon Foundation | 2024-516510-38-00 |
| MS200569_0003 | Phase 2 | MSD Merck Sharp | 2024-510872-18-00 |
| Pariglasgene brecaparvovec | Phase 2 | Anaxis Pharma | 2023-504004-29-00 |
| ST-920 | Phase 2 | SANGAMO THERAPEUTICS | 2024-512700-18-00 |
| ST-920 | Phase 2 | SANGAMO THERAPEUTICS | 2024-512695-34-00 |
Related patents
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|---|---|---|
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Related hubs
FAQ
What is the FDA approval status of phentermine hydrochloride?
phentermine hydrochloride currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get phentermine hydrochloride regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to phentermine hydrochloride?
This spoke lists 97 published programs associated with phentermine hydrochloride in our pipeline index.