FDA · United States
penicillamine — FDA regulatory status
penicillamine (D-PENAMINE) 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
- D-PENAMINE
- Originator
- Alphapharm Pty Ltd
- Mechanism
- Copper chelating agent
- Target
- Copper
- Structured fields
- 8
Sponsor / originator context: Alphapharm Pty 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: Copper chelating agent. Target: Copper. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 221 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 |
|---|---|---|---|
| 811095 | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT01100853 |
| Behavioral Drug and HIV Risk Reduction Counseling | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT01389180 |
| Buprenorphine | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00000302, NCT00023283 |
| Buprenorphine + Naltrexone | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT01402492 |
| Buprenorphine/naloxone | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00015288, NCT00032955 |
| CTX001-111 | Phase 3 | Vertex Pharmaceuticals (Australia) | 2024-516894-57-00 |
| Casgevy 4 - 13 x 10^6 cells/mL dispersion for infusion | Phase 3 | Vertex Pharmaceuticals (Australia) | 2024-512654-19-00 |
| Dapagliflozin 10 mg | Phase 3 | AstraZeneca | NCT01730534 |
| Deferasirox | Phase 3 | Novartis India | NCT00171821 |
| Dronabinol | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT01020019 |
| Escitalopram | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00732901 |
| Extended treatment | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT00459953 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12331026 | Sulfonamido derivatives as cyclin-dependent kinase 2 inhibitors | US |
| 12331328 | CRISPR/Cas9-mediated exon-skipping approach for USH2A-associated usher syndrome | US |
| 12208167 | Coated tablets for pH-dependent release of benzgalantamine | US |
| 12201699 | Compositions and methods for promoting homology directed repair | US |
| 12188005 | NK cells with an increased antibody-dependent cellular toxicity (ADCC) against tumors | US |
| 12156877 | Methods of treating conditions related to a thiamine deficiency, a thiamine-dependent enzyme, or an associated cofactor | US |
| 12036231 | Cyclic dinucleotides as agonists of stimulator of interferon gene dependent signalling | US |
| 11963982 | CRISPR/RNA-guided nuclease systems and methods | US |
| 11952408 | HPV-specific binding molecules | US |
| 11945822 | Pyrazolo-triazine and/or pyrazolo-pxrimidine derivatives as selective inhibitor of cyclin dependent kinase | US |
| 11897932 | Receptors for ligand-dependent transcriptional regulation | US |
| 11801234 | Methods of treating APOL-1 dependent focal segmental glomerulosclerosis | US |
Related hubs
FAQ
What is the FDA approval status of penicillamine?
penicillamine 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 penicillamine 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 penicillamine?
This spoke lists 221 published programs associated with penicillamine in our pipeline index.