Drugs / ecallantide
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | KALBITOR | — | 2014-03-28 | fda.gov ↗ |
| Approved | US (FDA) | KALBITOR | — | 2009-12-01 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 25 trials · 2 missed | ||||||
| Phase 2 | NCT01832896 | Aug 2013 → Jul 2017 | hereditary angioedema | NYU Langone Health | Withdrawn | No outcome recorded |
| Phase 2 | NCT00888940 | Jun → Dec 2009 | — | Merck & Co., Inc. | Completed | Missed primary |
| Phase 2 | NCT00816023 | Mar → Dec 2009 | — | Merck & Co., Inc. | Completed | Missed primary |
| Phase 2 | NCT00448864 | May 2007 → Jul 2008 | — | Merck & Co., Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01826916 | Nov 2003 → Dec 2005 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT00457015 | Apr 2007 → Jun 2008 | hereditary angioedema | Shire | Completed | Met primary |
| Phase 3 | NCT00456508 | Apr 2007 → Jun 2010 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00262080 | Dec 2005 | hereditary angioedema | Shire | Completed | Met primary |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT01343823 Comparator | Jun 2011 → Jun 2012 | renin-angiotensin-aldosterone system-blocker-induced angioedema | Shire | Terminated | No outcome recorded |
| Phase 2 | NCT01036659 Comparator | May 2010 → Jun 2013 | angioedema | Bernstein, Jonathan A., M.D. | Unknown | No outcome recorded |
| Phase 2/3 | NCT01253382 Comparator | Jun 2012 → Apr 2015 | hereditary angioedema | Shire | Withdrawn | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ecallantide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01826916 ↗ |
| Known as | DX-88 | “DX-88 (ecallantide)” NCT01826916 ↗ |
| Action | Inhibit | “Ecallantide is a plasma kallikrein inhibitor indicated for treatment of HAE attacks in patients aged 16 years and older.” PMID 23878046 ↗ Jul 2013 |
| Modality | Protein / enzyme biologic | “Recombinant Plasma Kallikrein Inhibitor” NCT00262080 ↗ |
| Route | Subcutaneous | “dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections.” NCT00262080 ↗ |