Plozasiran
Also known as Redemplo, Plozasiran sodium
ARROWHEAD PHARMACEUTICALS, INC. ARWR · Severe Hypertriglyceridemia; Hypertriglyceridemia; Familial Chylomicronemia
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
6
From ClinicalTrials.gov
Latest FDA action
Approved
NDA219947,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ARROWHEAD PHARMACEUTICALS, INC. ARWR Source: Company record for ARROWHEAD PHARMACEUTICALS, INC. (opens in a new tab)
- Indications
- Severe Hypertriglyceridemia; Hypertriglyceridemia; Familial Chylomicronemia Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 219947 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 219947 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 14 Dec 20216 linked trials
- Filed Completed
- Approved Current stageFirst approval 18 Nov 2025
The evidence trail loads here.
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Plozasiran. Editors add each one with its source.
Filed application
No filed application is on record for Plozasiran. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Plozasiran.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06880770ClinicalTrials.gov record for NCT06880770 (opens in a new tab)SHASTA-5 | Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis | Phase 3 | Recruiting | 288 (estimated) | Mar 2029 (estimated) | No |
| NCT06822790ClinicalTrials.gov record for NCT06822790 (opens in a new tab)SHASTA-10 | Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia | Phase 3 | Active, not recruiting | 710 (actual) | Jul 2028 (estimated) | No |
| NCT06347016ClinicalTrials.gov record for NCT06347016 (opens in a new tab)SHASTA-4 | Study of Plozasiran in Adults With Severe Hypertriglyceridemia | Phase 3 | Completed | 311 (actual) | 17 Jun 2026 (actual) | No |
Publications listing SHASTA-4 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT06347003ClinicalTrials.gov record for NCT06347003 (opens in a new tab)SHASTA-3 | Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia | Phase 3 | Completed | 446 (actual) | 12 Jun 2026 (actual) | No |
Publications listing SHASTA-3 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT06347133ClinicalTrials.gov record for NCT06347133 (opens in a new tab)MUIR-3 | Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia | Phase 3 | Completed | 1,456 (actual) | 1 Jun 2026 (actual) | No |
| NCT05089084ClinicalTrials.gov record for NCT05089084 (opens in a new tab)PALISADE | Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS) | Phase 3 | Completed | 75 (actual) | 29 Apr 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT05089084 (opens in a new tab) |
Posted results on ClinicalTrials.gov for PALISADE
Serious adverse events (Screening through Month 12 (Randomized Period)): Placebo (Pooled) 7 of 25; ARO-APOC3 (Plozasiran) 25 mg 5 of 26; ARO-APOC3 (Plozasiran) 50 mg 2 of 24 Source: ClinicalTrials.gov results for NCT05089084 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing PALISADE (2), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA219947Action letter for NDA219947 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
AuthorisedOrphan medicine
Redemplo (EMEA/H/C/006579)
- Authorised
- Therapeutic area
- Hyperlipoproteinemia Type I
- Marketing authorisation holder
- Arrowhead Pharmaceuticals Ireland Limited
- Active substance (INN)
- plozasiran
- ATC code
- C10AX
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Redemplo (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 219947 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06880770 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06822790 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06347016 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06347003 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06347133 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05089084 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA219947 (opens in a new tab) Licence: cc0. Fetched
Record updated .
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