U.S. label record. The cited DailyMed label identifies Ziconotide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗
Review source snapshots checked September 15, 2026 · Integrity checked September 15, 2026.
Three selected placebo-controlled trials examined intrathecal ziconotide for severe refractory pain. Intrathecal delivery and the studied populations are essential context; these are not general-use pain studies.↗↗↗
What the reviewed sources report
The trials reported greater short-term pain-score improvements than placebo, with neurological and other adverse effects. Differences in trial duration and exposure schedules limit comparisons among studies.↗↗↗
What remains unresolved?
What do current regulatory warnings specify about psychiatric and neurological risks?↗↗↗
How do longer observational reports address durability, discontinuation and uncommon harms?↗↗↗
The cited label concerns intrathecal management of severe chronic pain in adults for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatment. This is a specialized route and population. Label: 1 ↗
Which safety limits matter?
The boxed warning addresses severe psychiatric and neurological effects; pre-existing psychosis is a contraindication. Other intrathecal contraindications include relevant infection, uncontrolled bleeding problems and obstruction impairing cerebrospinal-fluid circulation. Pediatric safety and effectiveness have not been established. Label: 1, 4, 5, 8.4, boxed warning ↗
Label edition and source pins
U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.
Label ZIP SHA-256: a0b31d16771b167c912140ba2b59337f79cfddd632109f3ed8c1556065e8b9e5. Extracted XML SHA-256: 101aad729a27b6c532f9e28f511dcac5a723e305274e0a2703ecc1119c76a748.
Reviews summarize selected studies; their scope and limitations are shown above.
European medicine records · 1 products or applications
EMA medicine metadata checked 2026-09-15. These are product-specific centralized records; national European authorizations and full product-information assessments require separate coverage.
Active substance as listed: ziconotide. EMA record ↗
Marketing authorisation: 2005-02-21. EMA metadata last updated 2026-04-15. EMA metadata ↗
Application withdrawal and refusal are distinct from marketing authorization. A withdrawal status alone does not establish why it occurred. These metadata entries do not substitute for indication, population or safety details in the relevant product information.
Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.
Identity/name search without publication-type filtering; primary human reports, extensions, combinations and other reports require separate eligibility decisions. Known selected reports were recovered.
402 retrieved · 3 included · 0 excluded · 399 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"ziconotide"[Title/Abstract] OR "Prialt"[Title/Abstract] OR "SNX-111"[Title/Abstract]
Full-text appraisal and screening of unassessed records remain open.
Registry comparison, additional aliases and references, and regulator reconciliation require separate checks.
Showing 25 of 402 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 16716870 — include: Selected human report; abstract and record metadata reviewed. Study families: ziconotide-PMID16716870-registry-linkage-unresolved.
PubMed 22151630 — include: Selected human report; abstract and record metadata reviewed. Study families: ziconotide-PMID22151630-registry-linkage-unresolved.
PubMed 14709577 — include: Selected human report; abstract and record metadata reviewed. Study families: ziconotide-PMID14709577-registry-linkage-unresolved.
PubMed 42361918 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42710948 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42242129 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42676398 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42656698 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42548796 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42304757 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42161298 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42356430 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42227528 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42193237 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 42189020 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41910723 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41888060 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41628204 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 29083772 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41263096 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41255849 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 40907630 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41229894 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 38954510 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
PubMed 41079656 — not screened: Retrieved identity/name match; clinical eligibility has not yet been adjudicated.
FDA search
Active-ingredient name query in openFDA Drugs@FDA. Returned application identities include salt forms and combination products; exact indications, approval conditions, supplements and marketing status require document-level review.
1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Zero results describe this query response only, not absence of FDA approval or worldwide nonapproval.
This endpoint does not inventory every label, advisory proceeding, safety communication or regulatory document. Application inclusion does not establish current marketing or approval of every use.
Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
FDA NDA021060 — include: Retrieved application lists a matching ingredient or its salt; document and product review remain separate. Listed ingredients: ZICONOTIDE ACETATE.
EMA search
Local matching in the pinned EMA medicines feed; document matches also use identified EMA product numbers. This is not every national European record.
1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA EMEA/H/C/000551 — include: EMA feed product Prialt; reported status: Authorised. Exact indication and decision documents remain unappraised.
EMA search
Local matching in the pinned EMA documents feed; document matches also use identified EMA product numbers. This is not every national European record.
8 retrieved · 7 included · 0 excluded · 1 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 8 of 8 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA 15310 — include: Document linked by EMA product number; content unappraised. Prialt : EPAR - Procedural steps taken before authorisation
EMA 25422 — include: Document linked by EMA product number; content unappraised. Prialt : EPAR - Summary for the public
EMA 28859 — include: Document linked by EMA product number; content unappraised. Prialt : EPAR - All Authorised presentations
EMA 28994 — include: Document linked by EMA product number; content unappraised. Prialt : EPAR - Scientific Discussion
EMA 35884 — include: Document linked by EMA product number; content unappraised. Prialt : EPAR - Procedural steps taken and scientific information after authorisation (archive)
EMA 71727 — include: Document linked by EMA product number; content unappraised. Prialt : EPAR - Procedural steps taken and scientific information after authorisation
EMA 30162 — include: Document linked by EMA product number; content unappraised. Prialt : EPAR - Product Information
EMA 22784 — not screened: Title-name match awaiting identity and document review. EU/3/01/048: Public summary of positive opinion for orphan designation of ziconotide (intraspinal use) for the treatment of chronic pain requiring intraspinal analgesia
EMA search
Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.
1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA EU/3/01/048 — include: EMA orphan feed identifies ziconotide; designation status: Expired. Orphan designation is not marketing authorization.
ClinicalTrials.gov search
ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.
14 retrieved · 0 included · 0 excluded · 14 awaiting a decision · 0 full-text appraisals
Registration is not evidence that a study succeeded, that results were published, or that a use is approved.
Other registries, unregistered studies and additional aliases remain outside this query.
Showing 14 of 14 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov NCT00002160 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT04321408 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT06541184 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03942848 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07733427 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01888120 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT07499882 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01373983 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT01992562 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT02268812 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00047749 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT03321955 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00076544 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
ClinicalTrials.gov NCT00996983 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
Read the full Human Evidence Review
Supervised synthesis
What do selected human studies report about Ziconotide?
Three selected placebo-controlled trials examined intrathecal ziconotide for severe refractory pain. Intrathecal delivery and the studied populations are essential context; these are not general-use pain studies.123
Bottom line from this bounded source set
The trials reported greater short-term pain-score improvements than placebo, with neurological and other adverse effects. Differences in trial duration and exposure schedules limit comparisons among studies.123
Reviewed study record
Severe chronic pain: three-week trial
Design
Randomized placebo-controlled study with gradual exposure adjustment over three weeks.1
Population
112 people were assigned ziconotide and 108 placebo.1
Outcomes reported
Mean pain-score improvement was 14.7% versus 7.2%. Reported adverse effects included dizziness, confusion, impaired coordination, abnormal gait and memory impairment.1
Limitations
The short trial cannot establish durable benefit or uncommon harms. Similar discontinuation rates do not remove the neurological safety concerns.1
Reviewed study record
Pain associated with cancer or AIDS
Design
Randomized, double-blind, placebo-controlled trial with a brief initial comparison followed by maintenance or crossover.2
Population
111 adults with severe refractory cancer- or AIDS-associated pain were enrolled.2
Outcomes reported
Mean pain-intensity improvement during the initial comparison was 53.1% versus 18.1%.2
Limitations
Brief comparison, crossover and a highly selected population limit long-term interpretation. The abstract does not give a sufficiently detailed adverse-event account.2
Reviewed study record
Severe nonmalignant pain
Design
Randomized, double-blind, placebo-controlled inpatient trial over six days.3
Population
169 participants received ziconotide and 86 placebo.3
Outcomes reported
Mean pain-score reduction was 31.2% versus 6.0%. Adverse events prompted a protocol exposure reduction and included gait and visual disturbances, dizziness, nausea and urinary retention.3
Limitations
Rapid exposure adjustment contributed to substantial adverse effects. The short historical protocol is study context, not a treatment recommendation.3
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1016/j.jpainsymman.2005.10.003. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1001/jama.291.1.63. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1111/j.1525-1403.2006.00055.x. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
Explore status sources, recent additions, and coverage gaps
Living status brief
What is the current status of Ziconotide?
U.S. label record. The cited DailyMed label identifies Ziconotide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗
The cited status sources were checked through July 22, 2026. This answer changes only through the profile’s visible version and correction history.
PeptideScanner currently has no selected safety records connected to this profile. That is a collection gap, not evidence that no such records exist.
PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.
This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.
Status at observationCompleted 1Not yet recruiting 1Recruiting 1
A phase value is unavailable here for 4 selected records; this is not counted as “no phase.”
A status value is unavailable here for 1 selected record; this is not counted as a trial status.
PubMed bibliography
Publication composition
22 of 46 selected PubMed records include attributed title, venue, publication date, and publication-type fields.
Publication typesJournal Article 20Review 5Case Reports 4Comment 2Comparative Study 2Letter 2Research Support, Non-U.S. Gov't 2Clinical Trial 1Controlled Clinical Trial 1Evaluation Study 1Research Support, N.I.H., Extramural 1Research Support, U.S. Gov't, Non-P.H.S. 1Scoping Review 1Validation Study 1
Bibliography fields unavailable here for 24 selected records; the records remain visible as metadata observations.
Regulatory and publication surfaces
What is structurally connected?
Drugs@FDA applications
1
FDA Federal Register documents
1
DailyMed SPL versions
6
Canonical profile
Published
Profile structured data
Published
Linked dated records
58
Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.
PeptideScanner retained ClinicalTrials.gov record NCT01888120 at 2026-07-30T21:25:36.852Z. Its registry update date was 2017-03-16, and PeptideScanner's reviewed identity mapping was ziconotide.
PeptideScanner retained ClinicalTrials.gov record NCT04321408 at 2026-07-30T18:23:09.829Z. Its registry update date was 2025-08-17, and PeptideScanner's reviewed identity mapping was ziconotide.
DailyMed lists Structured Product Labeling version 1 for the reviewed Ziconotide label family with a published date of 2018-10-29. PeptideScanner retained the exact versioned ZIP byte count and SHA-256 receipt without republishing its contents.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.
These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.
Evidence summary
What the cited records say
The cited DailyMed label identifies Ziconotide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗
This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.
PeptideScanner retained PubMed bibliographic metadata for PMID 42548796 at 2026-08-10T10:49:12.983Z. PubMed recorded a metadata revision date of 2026-08-04 and an Entrez history date of 2026-08-04. PeptideScanner associated this retained record with the identity slug ziconotide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41910723 at 2026-07-30T16:14:16.607Z. PubMed recorded a metadata revision date of 2026-06-15 and an Entrez history date of 2026-03-30. PeptideScanner associated this retained record with the identity slug ziconotide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 42189020 at 2026-07-30T16:20:45.877Z. PubMed recorded a metadata revision date of 2026-05-26 and an Entrez history date of 2026-05-26. PeptideScanner associated this retained record with the identity slug ziconotide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 39244617 at 2026-07-30T16:20:38.998Z. PubMed recorded a metadata revision date of 2026-05-18 and an Entrez history date of 2024-09-07. PeptideScanner associated this retained record with the identity slug ziconotide. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained ClinicalTrials.gov record NCT07499882 at 2026-07-30T16:22:22.324Z. Its registry update date was 2026-03-30, and PeptideScanner's reviewed identity mapping was ziconotide.↗
PubMed lists PMID 15212625 in Expert opinion on investigational drugs as Clinical Trial, Controlled Clinical Trial, Journal Article, Review, with publication-date metadata of 2004-07 (month precision). PeptideScanner associated the retained record with the identity slug ziconotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 15479926 in JAMA as Letter, Comment, with publication-date metadata of 2004-10-13 (day precision). PeptideScanner associated the retained record with the identity slug ziconotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 16225359 in The American journal of hospice & palliative care as Journal Article, Review, with publication-date metadata of 2005 Sep-Oct (source-text precision). PeptideScanner associated the retained record with the identity slug ziconotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 16323709 in The American journal of hospice & palliative care as Letter, Comment, with publication-date metadata of 2005 Nov-Dec (source-text precision). PeptideScanner associated the retained record with the identity slug ziconotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 16599651 in CNS drugs as Evaluation Study, Journal Article, with publication-date metadata of 2006 (year precision). PeptideScanner associated the retained record with the identity slug ziconotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 16703976 in Pain physician as Case Reports, Comparative Study, Journal Article, with publication-date metadata of 2006-04 (month precision). PeptideScanner associated the retained record with the identity slug ziconotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗
PubMed lists PMID 16849624 in The Annals of pharmacotherapy as Journal Article, Review, with publication-date metadata of 2006-07-18 (day precision). PeptideScanner associated the retained record with the identity slug ziconotide. These fields reproduce attributed bibliographic metadata and do not summarize or endorse the article's findings.↗