Drugs / Zaleplon
Zaleplon
also known as
CL 284,846 · L-846 · LJC 10846 · SKP-1041 · Sonata · ZAL-846 · Zaleplon AP · Zaleplon civ · +2 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Sonata | — | 2015-07-03 | europa.eu ↗ |
| Label expansion | US (FDA) | SONATA | — | 2001-02-22 | fda.gov ↗ |
| Approved | US (FDA) | SONATA | — | 1999-08-13 | fda.gov ↗ |
| Approved | EU (EMA) | Sonata | — | 1999-03-12 | europa.eu ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials · 2 met primary | ||||||
| Phase 1 | NCT00620620 | Feb → Mar 2008 | — | Alexza Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00829868 | Feb → Mar 2004 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT00829998 | Feb 2004 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT03489304 | Apr 2014 → Feb 2015 | HIV infectious disease, depressive disorder | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT01277107 | Jan → Sep 2011 | insomnia | Intec Pharma Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00878553 | May → Dec 2010 | insomnia | Somnus Therapeutics, Inc. | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01159652 | Oct 2010 → May 2011 | — | St. Luke's Hospital, Chesterfield, Missouri | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT03526575 Comparator | Jan 2011 → Jul 2015 | — | National Aeronautics and Space Administration (NASA) | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2005-11-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval of Zaleplon Capsules tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Zaleplon Capsules, 5 mg and 10 mg. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2005-11-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval of Zaleplon Capsules tevapharm.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Zaleplon | “10 mg Zolpidem (Ambien) and 10 mg Zaleplon (Sonata)” NCT03526575 ↗ |
| Known as | CL 284,846 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1521 ↗ |
| Known as | L-846 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1521 ↗ |
| Known as | LJC 10846 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1521 ↗ |
| Known as | SKP-1041 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00878553 ↗ |
| Known as | Sonata | “10 mg Zolpidem (Ambien) and 10 mg Zaleplon (Sonata)” NCT03526575 ↗ |
| Known as | ZAL-846 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1521 ↗ |
| Known as | Zaleplon AP | “Gastric Retentive Dual Release Zaleplon (Zaleplon AP)” NCT01277107 ↗ |
| Known as | Zaleplon civ | ChEMBL registry synonym — accepted as the source's own label CHEMBL1521 ↗ |
| Known as | Zaleplone | ChEMBL registry synonym — accepted as the source's own label CHEMBL1521 ↗ |
| Known as | Zerene | ChEMBL registry synonym — accepted as the source's own label CHEMBL1521 ↗ |
| Modality | Small molecule | — CHEMBL1521 ↗ |
| Route | Oral | “administered orally” NCT00878553 ↗ |