ziconotide
Trade name: prialt
Approved
Dec 28, 2004
Ziconotide (PRIALT; SNX-111) is a neuroactive peptide, which was approved by FDA in 2004 for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. Ziconotide acts as a selective N-type voltage-gated calcium channel blocker, which leads to a blockade of excitatory neurotransmitter release from the primary afferent nerve terminals. — NCATS
Clinical trial activity
7 trials · 6 clinical orgs · 2 marketing orgs
Earliest trial started Nov 2, 1999 (NCT00002160)
Timeline
1990s
- Jan 1, 1999
Earliest Phase 2 Sponsor(trial)
2000s
- Jan 1, 2002
Elan Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
- Dec 28, 2004
Elan Pharmaceuticals — Earliest FDA Approval
- Dec 28, 2004
Tersera Theraps Llc — Marketing Organization
- Dec 28, 2004
Tersera Theraps Llc — NDA Secondary Org
- Dec 28, 2004
Elan Pharmaceuticals — NDA Organization
Indications
Approved for
Mechanism of action
Approval history
- approvedPriority reviewDec 28, 2004
Chemistry & pharmacology
SMILES
CSCC[C@@H]1NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@@H]3NC(=O)[C@H](CO)NC(=O)CNC(=O)[C@@H](NC(=O)[C@H](CSSC[C@H](N)C(=O)N[C@@H](CCCCN)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)NCC(=O)N[C@@H](C)C(=O)N[C@@H](CCCCN)C(=O)N2)NC(=O)[C@H](CSSC[C@H](NC(=O)[C@H](CCCCN)NC(=O)CNC(=O)[C@H](CO)NC(=O)[C@H](CCCNC(=N)N)NC3=O)C(=O)N)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](Cc4ccc(O)cc4)NC1=O)[C@@H](C)O- Mol. weight
- 2639.19 g/mol
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaZiconotide ↗
- NCATS7I64C51O16 ↗
- ChEMBLCHEMBL4594214 ↗
- ChEMBLCHEMBL2103752 ↗
- ChEMBLCHEMBL1795072 ↗
Also known as
- cys-lys-gly-lys-gly-ala-lys-cys-ser-arg-leu-met-tyr-asp-cys-cys-thr-gly-ser-cys-arg-ser-gly-lys-cys-nh2
- omega-conopeptide mviia
- omega-conopeptide mviia (conus)
- omega-conotoxin mviia
- omega-conotoxin m viia
- omega-conotoxin mviia, conus magus
- prialt
- prialt
- prialt
- prialt
- prialt
- snx 111
- snx-111
- snx-111
- snx-111
- ziconotide
- ziconotide
- ziconotide
- ziconotide
- ziconotide
- ziconotide
- ziconotide
- ziconotide
- ziconotide
- ziconotide
- ziconotide
- ziconotide acetate
- ziconotide acetate
- ziconotide acetate
- ziconotide acetate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03321955 | Phase 4 | Nov 3, 2016 | Albany Medical College |
| NCT01992562 | Phase 4 | Oct 1, 2013 | Ohio State University |
| NCT01373983 | Phase 4 | Aug 1, 2011 | Linkoping University |
| NCT00996983 | Phase 2 | Sep 1, 2009 | Fondazione Giovanni Pascale |
| NCT00076544 | Phase 3 | Feb 1, 2004 | Elan Pharmaceuticals |
| NCT00047749 | Phase 3 | Aug 1, 2002 | Elan Pharmaceuticals |
| NCT00002160 | Phase 2 | Nov 2, 1999 | Neurex |
Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Elan Pharmaceuticals | For profit | 2 | 2 | 1 | 2002 |
| Albany Medical College | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Fondazione Giovanni Pascale | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Linkoping University | Academic/Hospital | 1 | 1 | 1 | 2011 |
| Neurex | For profit | 1 | 1 | 1 | 1999 |
| Ohio State University | Academic/Hospital | 1 | 1 | 1 | 2013 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Elan Pharmaceuticals | For profit | NDA | Dec 28, 2004 |
| Tersera Theraps Llc | For profit | MKTG | Dec 28, 2004 |
| Tersera Theraps Llc | For profit | NDA2 | Dec 28, 2004 |