Berotralstat

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Berotralstat
File:Berotralstat Structure.svg
Clinical data
Trade namesOrladeyo
Other namesBCX7353, BCX-7353
AHFS/Drugs.comMonograph
License data
Routes of
administration		By mouth
Drug classPlasma kallikrein inhibitor
ATC code
Legal status
Legal status
Identifiers
  • 2-[3-(aminomethyl)phenyl]-N-[5-[(R)-(3-cyanophenyl)-(cyclopropylmethylamino)methyl]-2-fluorophenyl]-5-(trifluoromethyl)pyrazole-3-carboxamide
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
E number{{#property:P628}}
CompTox Dashboard (EPA)
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Chemical and physical data
FormulaC30H26F4N6O
Molar mass562.573 g·mol−1
3D model (JSmol)
  • NCC1=CC(=CC=C1)N1N=C(C=C1C(=O)NC1=CC(=CC=C1F)[C@H](NCC1CC1)C1=CC=CC(=C1)C#N)C(F)(F)F
  • InChI=1S/C30H26F4N6O/c31-24-10-9-22(28(37-17-18-7-8-18)21-5-1-3-19(11-21)15-35)13-25(24)38-29(41)26-14-27(30(32,33)34)39-40(26)23-6-2-4-20(12-23)16-36/h1-6,9-14,18,28,37H,7-8,16-17,36H2,(H,38,41)/t28-/m1/s1
  • Key:UXNXMBYCBRBRFD-MUUNZHRXSA-N

Berotralstat, sold under the brand name Orladeyo, is a medication used to prevent attacks of hereditary angioedema.[3][5][7][8][4] Berotralstat is a plasma kallikrein inhibitor.[3] It is taken by mouth.[3]

The most common side effects include abdominal pain, vomiting, diarrhea, back pain, and heartburn.[4]

Berotralstat was approved for medical use in the United States in December 2020,[3][4][9] and in the European Union in April 2021.[5]

Medical uses

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Berotralstat is indicated for prophylaxis to prevent attacks of hereditary angioedema.[3][10]

History

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Berotralstat was approved based on evidence from one clinical trial (Trial 1 / NCT03485911) of 120 participants with hereditary angioedema.[4] The trial was conducted at 40 sites in the United States, the European Union, and Canada.[4] Trial investigators evaluated participants twelve years of age and older[11] with hereditary angioedema for eight weeks to determine the number of attacks for each participant.[4] The trial enrolled only participants who had at least two attacks during the eight-week period.[4] Participants were assigned to receive one of two doses of berotralstat or placebo once every day for 24 weeks.[4] Neither the participants nor the investigators knew which treatment was being given until after the trial was completed.[4] All participants could use other medications for treatment of attacks.[4]

Society and culture

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Berotralstat was approved for medical use in the United States in December 2020,[4] and in the European Union in April 2021.[5]

Names

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Berotralstat is the international nonproprietary name.[12]

References

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  1. ^ Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
  2. ^ Product monograph hres.ca
  3. ^ a b c d e f Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
  4. ^ a b c d e f g h i j k l Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value). Public Domain This article incorporates text from this source, which is in the public domain.
  5. ^ a b c d Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
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  12. ^ Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
[edit | edit source]
  • Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
  • Lua error in Module:Citation/CS1/Configuration at line 2172: attempt to index field '?' (a nil value).
  • Clinical trial number NCT03485911 for "Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE (APeX-2)" at ClinicalTrials.gov

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