Drugs / Amifampridine
Amifampridine
also known as
3,4-Diaminopyridine · 3,4DAP · Amifampridine Phosphate · DAP · 3,4-DAPP · 3,4-diammoniopyridinium · 4-DAP · Amifampridina · +9 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | FIRDAPSE | — | 2022-09-29 – 2024-05-30 | fda.gov ↗ |
| Approved | US (FDA) | FIRDAPSE | — | 2018-11-28 | fda.gov ↗ |
| Approved | EU (EMA) | Firdapse (previously Zenas) | — | 2009-12-23 | europa.eu ↗ |
Trials 27 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT01511978 Comparator | Jan 2012 → Feb 2014 | Lambert-Eaton myasthenic syndrome | Jacobus Pharmaceutical | Completed | No outcome recorded |
| Phase 2 | NCT00342381 Comparator | Jun 2006 → Dec 2007 | multiple sclerosis | University of Aarhus | Completed | No outcome recorded |
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | amifampridine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02970162 ↗ |
| Known as | 3,4-DAPP | ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗ |
| Known as | 3,4-Diaminopyridine | “A new drug called 3,4-Diaminopyridine (3,4-DAP) is currently under investigation for treatment of the symptoms of Lambert-Eaton Myasthenic Syndrome (LEMS).” NCT00704925 ↗15“Compassionate use of orphan drug 3,4-Diaminopyridine(DAP) in Treatment of Lambert Eaton Myasthenic Syndrome (LEMS).” NCT01373333 ↗ “oral 3,4-diaminopyridine (3,4-DAP) or placebo administered for 4 days” NCT00004939 ↗ |
| Known as | 3,4-diammoniopyridinium | ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗ |
| Known as | 3,4DAP | “A new drug called 3,4-Diaminopyridine (3,4-DAP) is currently under investigation for treatment of the symptoms of Lambert-Eaton Myasthenic Syndrome (LEMS).” NCT00704925 ↗6“3,4diaminopyridine (3,4DAP)is a drug that has been demonstrated to be effective in treating the weakness associated with LEMS” NCT01378546 ↗ “The 3,4-diaminopyridine (3,4-DAP) is a pharmacological Ito blocker that can be used in humans.” NCT00701077 ↗ “oral 3,4-diaminopyridine (3,4-DAP) or placebo administered for 4 days” NCT00004939 ↗ |
| Known as | 4-DAP | ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗ |
| Known as | Amifampridina | ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗ |
| Known as | Amifampridine Phosphate | “Amifampridine Phosphate 10 MG Oral Tablet” NCT03819660 ↗1“Drug: Amifampridine Phosphate” NCT03579966 ↗ |
| Known as | Amifampridine serb | ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗ |
| Known as | DAP | “Evaluate the safety and effectiveness of 3,4-diaminopyridine (DAP) in the treatment of patients with Lambert-Eaton myasthenic syndrome (LEMS).” NCT00004832 ↗1“Compassionate use of orphan drug 3,4-Diaminopyridine(DAP) in Treatment of Lambert Eaton Myasthenic Syndrome (LEMS).” NCT01373333 ↗ |
| Known as | DAPP | ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗ |
| Known as | Dynamine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03937687 ↗ |
| Known as | FIRDAPSE | “Evaluate the effectiveness of an administration of 3,4-diaminopyridine (FIRDAPSE ®) in severe botulinic poisoning in measuring the effect on electrophysiological and...” NCT01441557 ↗ |
| Known as | Firdapse (previously zenas) | ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗ |
| Known as | NSC-521760 | ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗ |
| Known as | Pyridine-3,4-diamine | ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗ |
| Known as | Ruzurgi | ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗ |
| Known as | Zenas | ChEMBL registry synonym — accepted as the source's own label CHEMBL354077 ↗ |
| Action | Inhibit | “3,4-DAP is a pharmacological Ito blocker” NCT00701077 ↗ |
| Modality | Small molecule | — CHEMBL354077 ↗ |
| Route | Oral | “patients are randomized to receive 3,4-diaminopyridine (DAP) or placebo orally 3 times daily for 5 days” NCT00004832 ↗ |