Plozasiran

Highest phase reached
Drug type
Oligonucleotide

Listing at source
Listed
Highest phase reached

Drug type
Oligonucleotide
Drug name
Plozasiran

  • ads 005
  • ads 005 free acid
  • ADS-005
  • ADS-005 FREE ACID
  • plozasiran
  • Plozasiran
  • plozasiran [INN]
  • PLOZASIRAN [USAN]
  • Plozasiran [WHO-DD]
  • plozasiran inn
  • plozasiran usan
  • plozasiran who dd

ATC classification codes
  • C10AX
CAS registry numbers
  • 2379776-40-4
ChEMBL ID
CHEMBL6068438
RxNorm IDs (RxCUI)
  • 2727175
FDA ingredient codes (UNII)
  • XG9ARL6P25

Status
Authorised
Status date
19 Jun 2026
Authorisation date
19 Jun 2026
Approved indications
Redemplo is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with familial chylomicronaemia syndrome (FCS) (see section 4.2 for patient selection criteria).
Product number
EMEA/H/C/006579
Authorisation holder
Arrowhead Pharmaceuticals Ireland Limited
Priority medicines scheme
No
Generic
No
Biosimilar
No
Generic medicines
0
Biosimilar medicines
0
Advanced therapy
No
Conditional approval
No
Additional monitoring
Yes
Accelerated assessment
No
Exceptional circumstances
No

Therapeutic areas

  • Hyperlipoproteinemia Type I
European medicines record

Patents
0
Designations
5
First in class
No
Fast track
Yes
Breakthrough designation
Yes
Orphan designation
Yes
Priority review
No
Orphan exclusivity
No
Accelerated approval
No

Pharmacology name
plozasiran
Type
Nucleic acid
Approval recorded by Guide to Pharmacology
Yes

  • Condition
    Hypertriglyceridemia
    Highest recorded phase
    1
    Condition identifier
    EFO:0004211
    Subject identifier
    D015228
  • Condition
    Dyslipidemias
    Highest recorded phase
    1
    Condition identifier
    HP:0003119
    Subject identifier
    D050171
  • Condition
    Hyperlipoproteinemia Type I
    Highest recorded phase
    1
    Condition identifier
    MONDO:0009387
    Subject identifier
    D008072

  • Condition identifier
    EFO_0004211
    Highest recorded phase
    3
  • Condition identifier
    HP_0003119
  • Condition identifier
    MONDO_0002525
    Highest recorded phase
    2
  • Condition identifier
    MONDO_0005347
    Highest recorded phase
    3
  • Condition identifier
    MONDO_0006515
    Highest recorded phase
    3
  • Condition identifier
    MONDO_0009387
  • Condition identifier
    MONDO_0009387
    Highest recorded phase
    3
  • Condition identifier
    MONDO_0018637
    Highest recorded phase
    3
  • Condition identifier
    Orphanet_79211
    Highest recorded phase
    2

Prodrug
No
Chirality
Single enantiomer
Inorganic
No
Natural product
No

Sequences

  • Component
    Sequence
    Type
    Nucleic Acid
    Sequence
    (3'-5') U-G-C-C-C-U-G-U-C-A-U-A-A-G-A-G-U-C=A=C=U (5'-3') A-C-G-G-G-A-C-A-G-U-A-U-U-C-U-C-A-G-U-I-A

  • 84141-025

Related records

Trials (8)

In development for (2)