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Drug ReportsSebetralstat
Sebetralstat
Ekterly (sebetralstat) is a small molecule pharmaceutical. Sebetralstat was first approved as Ekterly on 2025-07-03.
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Drug
Target
Variants
Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Ekterly
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sebetralstat
Tradename
Company
Number
Date
Products
EKTERLYKalVista PharmaceuticalsN-219301 RX2025-07-03
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ekterlyNew Drug Application2025-07-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hereditary angioedemasEFO_0004131D054179—
Agency Specific
FDA
EMA
Expiration
Code
SEBETRALSTAT, EKTERLY, KALVISTA
2030-07-03NCE
2030-07-03NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Sebetralstat, Ekterly, Kalvista
112349392039-01-26DPU-4223
112305372037-12-25DS, DP
117390682037-06-23U-4223
103642382035-11-26DS, DP
106117582035-11-26U-4223
110015782035-11-26DS, DP
110848092035-11-26DS, DPU-4223
111986912035-11-26U-4223
112349392039-01-26DPU-4223
112305372037-12-25DS, DP
117390682037-06-23U-4223
103642382035-11-26DS, DP
106117582035-11-26U-4223
110015782035-11-26DS, DP
110848092035-11-26DS, DPU-4223
111986912035-11-26U-4223
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
8 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hereditary angioedemasD054179EFO_0004131—114—28
AngioedemaD000799EFO_0005532T78.3113—16
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hereditary angioedema types i and iiD056829———1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSebetralstat
INNsebetralstat
Description
Sebetralstat is an oral on-demand therapy to treat acute hereditary angioedema (HAE) attacks. It is designed to reduce the severity and duration of HAE attacks by inhibiting plasma kallikrein, an enzyme that plays a key role in swelling during HAE attacks. Sebetralstat is marketed under the brand name EKTERLY and was approved by the U.S. Food and Drug Administration (FDA) in July 2025 for use in adults and children aged 12 years of age and older. It represents the first orally administered treatment option for acute HAE attacks.
Classification
Small molecule
Drug classenzyme inhibitors: 1) kallikrein inhibitors or 2) serine protease inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COCc1nn(Cc2ccc(Cn3ccccc3=O)cc2)cc1C(=O)NCc1nccc(OC)c1F
Identifiers
PDB—
CAS-ID1933514-13-6
RxCUI—
ChEMBL IDCHEMBL5095248
ChEBI ID—
PubChem CID121365142
DrugBankDB18305
UNII IDO5ZD2TU2B7 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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