Drugs / nafcillin
nafcillin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | UNIPEN | — | 1985-09-05 | fda.gov ↗ |
| Approved | US (FDA) | UNIPEN | — | 1965-10-11 | fda.gov ↗ |
Trials 2 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05001750 | Jun 2021 → Jun 2026 overdue | cerebritis, hydrocephalus, intracerebral hemorrhage, subarachnoid hemorrhage | Montefiore Medical Center | Recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07376889 | Feb 2026 → Jan 2029 expected | staphylococcus aureus infection | Intermountain Health Care, Inc. | Not yet recruiting | No outcome recorded |
Also used as a comparator or background therapy in 14 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT04775953 Comparator | Apr 2021 → Oct 2023 | staphylococcal infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT01756924 Comparator | Dec 2012 → Jul 2014 | periprosthetic joint infection | Arrevus Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00428844 Comparator | Jun 2007 → Mar 2010 | osteomyelitis | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00303589 Comparator | Dec 2005 → Oct 2007 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT00077675 Comparator | Feb → Sep 2004 | gram-positive bacterial infections | Cumberland Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00062647 Comparator | Aug 2003 → Aug 2006 | gram-positive bacterial infections | Cumberland Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00061633 Comparator | Jun 2003 → Jan 2004 | abscess, cellulitis, gram-positive bacterial infections, ulcer disease | Cumberland Pharmaceuticals | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02344511 Comparator | Mar 2016 → Oct 2018 | osteomyelitis | Durata Therapeutics International BV (an Affiliate of Actavis, Inc.) | Withdrawn | No outcome recorded |
| Phase 3 | NCT02208063 Comparator | Dec 2014 → Apr 2018 | bacterial infectious disease | Cumberland Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT01922011 Comparator | Sep 2013 → Jun 2016 | osteomyelitis | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT07148960 Comparator | Sep 2025 → Jul 2027 expected | staphylococcus aureus infection | West Virginia University | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT01104662 Comparator | Apr 2010 → Jun 2012 | impaired renal function disease, staphylococcus aureus infection | Merck & Co., Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT00711802 Comparator | Jul 2008 → Oct 2013 | skin disease caused by bacterial infection | Merck & Co., Inc. | Completed | No outcome recorded |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nafcillin | “Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up...” NCT00061633 ↗15“nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.” NCT00077675 ↗ “Intravenous anti-staphylococcal beta-lactam, either cefazolin or nafcillin, per the discretion of the treating physician.” NCT07376889 ↗ “Participant given one of the following IV therapies: cefazolin, oxacillin, or nafcillin.” NCT07148960 ↗ “Nafcillin 1-2 grams every 6 hours (depending on weight) until the EVD is removed.” NCT05001750 ↗ “PRP (nafcillin or flucloxacillin) or vancomycin, plus aztreonam or ciprofloxacin” NCT00303589 ↗ “penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin)” NCT01104662 ↗ “nafcillin, oxacillin, cloxacillin” NCT00711802 ↗ “Nafcillin” NCT02208063 ↗ “Nafcillin” NCT02099240 ↗ |
| Known as | Anhydrous nafcillin sodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL1443 ↗ |
| Known as | Nafcil | ChEMBL registry synonym — accepted as the source's own label CHEMBL1443 ↗ |
| Known as | Nafcilina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1443 ↗ |
| Known as | NAFCILLIN SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL1443 ↗ |
| Known as | Nafcillin sodium anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL1443 ↗ |
| Known as | Nafcillin sodium monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1443 ↗ |
| Known as | Nafcillin sodium salt anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL1443 ↗ |
| Known as | Nafcillin sodium salt monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1443 ↗ |
| Known as | Nafcilline | ChEMBL registry synonym — accepted as the source's own label CHEMBL1443 ↗ |
| Known as | Nallpen | ChEMBL registry synonym — accepted as the source's own label CHEMBL1443 ↗ |
| Known as | NSC-757108 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1443 ↗ |
| Known as | Sodium nafcillin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1443 ↗ |
| Known as | Sodium nafcillin monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1443 ↗ |
| Known as | Unipen | ChEMBL registry synonym — accepted as the source's own label CHEMBL1443 ↗ |
| Known as | WY-3277 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1443 ↗ |
| Modality | Small molecule | “semi-synthetic antibiotic related to penicillin” NCT04775953 ↗ |
| Route | Intravenous | “nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs” NCT00061633 ↗ |