FDA · United States
hexachlorophene — FDA regulatory status
hexachlorophene (SOY-DOME) 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
- SOY-DOME
- Originator
- ADIAL PHARMACEUTICALS, INC.
- Mechanism
- Bacterial enoyl-[acyl-carrier-protein] reductase inhibitor
- Target
- Enoyl-[acyl-carrier-protein] reductase [NADH] FabI
- Structured fields
- 8
Sponsor / originator context: ADIAL PHARMACEUTICALS, INC.. 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: Bacterial enoyl-[acyl-carrier-protein] reductase inhibitor. Target: Enoyl-[acyl-carrier-protein] reductase [NADH] FabI. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 94 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 |
|---|---|---|---|
| 20170724 | Phase 3 | Amgen | 2023-506471-10-00 |
| APHP 180610 | Phase 3 | PARItec | 2023-507296-21-00 |
| APHP 180610 | Phase 3 | PARItec | 2025-523349-86-00 |
| APHP180560 | Phase 3 | PARItec | 2024-514347-28-00 |
| APHP230855 | Phase 3 | PARItec | 2024-510602-90-00 |
| Alirocumab 150 MG/ML [Praluent] | Phase 3 | Regeneron UK | NCT03480568 |
| Auto-CD34+ cells | Phase 3 | Lisata Therapeutics | NCT01508910 |
| Autologous Peripheral Blood Stem Cell injection | Phase 3 | Hospital Authority | NCT06364150 |
| CKJX839A12309 | Phase 3 | Novartis India | 2025-521670-34-00 |
| COLCHICINE OPOCALCIUM 1 mg, comprimé sécable | Phase 3 | PARItec | 2024-513669-38-00 |
| ECULIZUMAB , ECULIZUMAB | Phase 3 | PARItec | 2024-516402-32-00 |
| Ear pills | Phase 3 | Universal Integrated | NCT02583802 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12351653 | Pharmaceutical compositions comprising novel cyclic peptides | US |
| 12162837 | Substituted 3-dialkylaminomethyl-piperidin-4-yl-benzamides and methods of making and using same | US |
| 12059418 | Plasmodial surface anion channel inhibitors for the treatment or prevention of malaria | US |
| 11884932 | In vitro production of medial ganglionic eminence precursor cells | US |
| 11851503 | Antiplasmodial compounds | US |
| 11725217 | Methods to enhance myocardial regeneration and/or repair | US |
| 11530240 | Catheter injectable cyclic peptide pro-gelators for myocardial tissue engineering | US |
| 11319290 | Substituted 3-dialkylaminomethyl-piperidin-4-yl-benzamides and methods of making and using same | US |
| 11230569 | Antiplasmodial compounds | US |
| 11141496 | Use of berberine or derivative thereof in preparing myocardial perfusion imaging agent | US |
| 10927135 | Metal-free direct arylation of dialkyl phosphonates for the synthesis of mixed alkyl aryl phosphonates | US |
| 10881669 | Inhibitors of the plasmodial surface anion channel as antimalarials | US |
Related hubs
FAQ
What is the FDA approval status of hexachlorophene?
hexachlorophene 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 hexachlorophene 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 hexachlorophene?
This spoke lists 94 published programs associated with hexachlorophene in our pipeline index.