donidalorsen 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antisense oligonucleotides 5796 None

Description:

MoleculeDescription

Molfile

Synonyms:

  • donidalorsen
  • dawnzera
  • IONIS-PKK-LRx
  • ISIS 721744
  • donidalorsen sodium
Donidalorsen is an ASO-GalNAc conjugate that causes ribonuclease H1 (RNase H1)-mediated degradation of PKK mRNA through binding to PKK mRNA, which results in reduced production of PKK protein. PKK is a pro-enzyme for plasma kallikrein, which results in the release of bradykinin, a potent vasodilator causing swelling and pain in HAE. In patients with HAE, C1-inhibitor (C1-INH) deficiency or dysfunction leads to excessive plasma kallikrein activity, bradykinin generation, and angioedema attacks. Donidalorsen lowers PKK concentration, preventing excessive bradykinin production in patients with HAE.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Aug. 21, 2025 FDA Ionis Pharmaceuticals, Inc.
Jan. 19, 2026 EMA Otsuka Pharmaceutical Netherlands B.V.

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B06AC09 BLOOD AND BLOOD FORMING ORGANS
OTHER HEMATOLOGICAL AGENTS
OTHER HEMATOLOGICAL AGENTS
Drugs used in hereditary angioedema
CHEBI has role CHEBI:22587 antiviral agent

Related Drugs by ATC class:

B06AC Drugs used in hereditary angioedema 7 drugs

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Hereditary angioneurotic edema indication 82966003 DOID:14735




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) DAWNZERA (AUTOINJECTOR) IONIS PHARMS INC N219407 Aug. 21, 2025 RX SOLUTION SUBCUTANEOUS 9315811 Oct. 21, 2032 PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) DAWNZERA (AUTOINJECTOR) IONIS PHARMS INC N219407 Aug. 21, 2025 RX SOLUTION SUBCUTANEOUS 10294477 May 1, 2035 PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) DAWNZERA (AUTOINJECTOR) IONIS PHARMS INC N219407 Aug. 21, 2025 RX SOLUTION SUBCUTANEOUS Aug. 21, 2032 PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Bioactivity Summary:

None

External reference:

IDSource
2304692-48-4 SECONDARY_CAS_RN
CHEMBL4650235 ChEMBL_ID
C000723381 MESH_SUPPLEMENTAL_RECORD_UI
4044242 VANDF
C5447584 UMLSCUI
CHEBI:758141 CHEBI
CHEMBL4650236 ChEMBL_ID
11653 INN_ID
2304701-45-7 SECONDARY_CAS_RN
44351 MMSL
d10307 MMSL
020204 NDDF
020205 NDDF
13610 IUPHAR_LIGAND_ID
ZD4D8M32TL UNII
2724361 RXNORM
C000711268 MESH_SUPPLEMENTAL_RECORD_UI
D13154 KEGG_DRUG

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DAWNZERA HUMAN PRESCRIPTION DRUG LABEL 1 71860-103 INJECTION, SOLUTION 80 mg SUBCUTANEOUS NDA 28 sections