Drugs / Ziconotide
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Prialt | — | 2005-02-21 | europa.eu ↗ |
| Approved | US (FDA) | PRIALT | — | 2004-12-28 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT00996983 | Sep 2009 → Dec 2024 | cancer, neuropathy, painful | National Cancer Institute, Naples | Unknown | No outcome recorded |
| Phase 2 | NCT00002160 | — | HIV infectious disease, cancer | Neurex | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT03942848 | Jun → Dec 2019 | neuropathy, painful, spinal cord disorder | Hospices Civils de Lyon | Unknown | No outcome recorded |
| Phase 3 | NCT00076544 | Feb 2004 → Mar 2005 | — | Elan Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00047749 | Aug 2002 → Jun 2003 | — | Elan Pharmaceuticals | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03321955 | Nov 2016 → Aug 2020 | neuropathy, painful | Albany Medical College | Completed | No outcome recorded |
| Phase 4 | NCT01992562 | Jan 2014 → Dec 2015 | neuropathy, painful | Aaron Boster | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01373983 | Aug 2011 → Dec 2014 | peripheral neuropathy | University Hospital, Linkoeping | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-07-18 | TerSera Therapeutics LLC | Results TerSera Therapeutics to Present Real-World Data on Intrathecal Ziconotide (PRIALT®) Prescription Patterns at ASPN 2025 tersera.com ↗
Use of ziconotide as monotherapy increased from 36.0% in 2017–2018 to 63.1% in 2023–2024, reflecting growing adoption of guideline-aligned prescribing of ziconotide. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-07-18 | TerSera Therapeutics LLC | TerSera Therapeutics to Present Real-World Data on Intrathecal Ziconotide (PRIALT®) Prescription Patterns at ASPN 2025 tersera.com ↗ |
| 2024-07-23 | TerSera Therapeutics LLC | TerSera Therapeutics LLC Announces that the 2024 Polyanalgesic Consensus Conference (PACC) Guidelines issued updated guidance for administering PRIALT tersera.com ↗ |
| 2018-07-29 | TerSera Therapeutics LLC | Jazz Pharmaceuticals Enters Into Agreement with TerSera Therapeutics LLC for Prialt tersera.com ↗ |
| 2018-06-29 | Jazz Pharmaceuticals | Jazz Pharmaceuticals Enters Into Agreement with TerSera Therapeutics LLC for Prialt jazzpharma.com ↗ |
| 2018-04-23 | Eisai Inc. | RIGHTS TO NON-OPIOID SEVERE CHRONIC PAIN TREATMENT PRIALT® TRANSFERRED TO RIEMSER eisai.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ziconotide | “The experimental treatment period consists of Ziconotide solution that will be prepared by each local pharmacy team” NCT03942848 ↗ |
| Known as | Prialt | “Prialt (ziconotide)” NCT00047749 ↗ |
| Route | Intrathecal | “intrathecal ziconotide” NCT00047749 ↗ |