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1. 1-(3-(aminomethyl)phenyl)-n-(5-((r)-(3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1h-pyrazole-5-carboxamide
2. 1h-pyrazole-5-carboxamide, 1-(3-(aminomethyl)phenyl)-n-(5-((r)-(3-cyanophenyl)((cyclopropylmethyl)
3. Bcx-7353
4. Bcx7353
5. Berotralstat
1. Berotralstat
2. 1809010-50-1
3. Bcx7353
4. Berotralstat [inn]
5. Berotralstat [usan]
6. Xza0kb1bdq
7. Bcx-7353
8. Berotralstat (usan)
9. 2-[3-(aminomethyl)phenyl]-n-[5-[(r)-(3-cyanophenyl)-(cyclopropylmethylamino)methyl]-2-fluorophenyl]-5-(trifluoromethyl)pyrazole-3-carboxamide
10. 1-(3-(aminomethyl)phenyl)-n-(5-((r)-(3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1h-pyrazole-5-carboxamide
11. 1h-pyrazole-5-carboxamide, 1-(3-(aminomethyl)phenyl)-n-(5-((r)-(3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-
12. 1-[3-(aminomethyl)phenyl]-n-(5-{(r)-(3-cyanophenyl)[(cyclopropylmethyl)amino]methyl}-2-fluorophenyl)-3-(trifluoromethyl)-1h-pyrazole-5-carboxamide
13. Unii-xza0kb1bdq
14. Berotralstat [usan:inn]
15. Berotralstat [who-dd]
16. Schembl21974728
17. Gtpl11347
18. Dtxsid401336676
19. Ex-a5537
20. Who 10907
21. Hy-109127
22. Cs-0086757
23. D11673
24. (r)-1-(3-(aminomethyl)phenyl)-n-(5-((3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1h-pyrazole-5-carboxamide
25. 0ri
26. 1-[3-(aminomethyl)phenyl]-n-(5-{(r)-[3-(aminomethyl)phenyl][(cyclopropylmethyl)amino]methyl}-2-fluorophenyl)-3-(trifluoromethyl)-1h-pyrazole-5-carboxamide
27. 1h-pyrazole-5-carboxamide, 1-(3-(aminomethyl)phenyl)-n-(5-((r)-(3-cyanophenyl)((cyclopropylmethyl)
Molecular Weight | 562.6 g/mol |
---|---|
Molecular Formula | C30H26F4N6O |
XLogP3 | 4.5 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 9 |
Rotatable Bond Count | 9 |
Exact Mass | 562.21042212 g/mol |
Monoisotopic Mass | 562.21042212 g/mol |
Topological Polar Surface Area | 109 Ų |
Heavy Atom Count | 41 |
Formal Charge | 0 |
Complexity | 938 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Berotralstat is indicated for prophylaxis of attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. It is not used for the treatment of acute HAE attacks.
Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
Berotralstat prevents angioedema attacks by inhibiting plasma kallikrein, thereby regulating excess bradykinin generation in patients with hereditary angioedema. It has a fast onset of action, long duration of action, and acceptable tolerance. Berotralstat inhibits plasma kallikrein in a concentration-dependent. In clinical trials, doses of berotralstat higher than 150 mg once daily led to QT Prolongation in a concentration-dependent manner.
Serine Proteinase Inhibitors
Exogenous or endogenous compounds which inhibit SERINE ENDOPEPTIDASES. (See all compounds classified as Serine Proteinase Inhibitors.)
B06AC
B - Blood and blood forming organs
B06 - Other hematological agents
B06A - Other hematological agents
B06AC - Drugs used in hereditary angioedema
B06AC06 - Berotralstat
Absorption
The steady-state of berotralstat is reached within 6 to 12 days following initial administration. After once-daily administration, the Cmax and AUC of berotralstat at steady-state is approximately five times that of the drug after a single dose. Following oral administration of berotralstat once-daily, the steady-state Cmax was 158 ng/mL (range: 110 to 234 ng/mL) at the dose of 150 mg and 97.8 ng/mL (range: 63 to 235 ng/mL) at the dose of 110 mg. The area under the curve over the dosing interval (AUCtau) was 2770 ng*hr/mL (range: 1880 to 3790 ng*hr/mL) and 1600 ng*hr/mL (range: 950 to 4170 ng*hr/mL) at the dose of 110 mg. The median Tmax is 2 hours in a fasted state and a high-fat meal delays the Tmax to 5 hours. The Tmax can range from 1 to 8 hours.
Route of Elimination
Following a single oral dose administration of 300 mg radiolabeled berotralstat, approximately 9% of the drug was excreted in the urine, where 1.8 to 4.7% of the total radiolabeled compound accounted for the unchanged parent drug. About 79% of the drug was excreted in feces.
Volume of Distribution
The blood to plasma ratio was approximately 0.92 following a single 300 mg dose administration of radiolabeled berotralstat.
Clearance
There is no information on the clearance rate.
Berotralstat is metabolized by CYP2D6 and CYP3A4. The metabolic pathway and the metabolites of berotralstat have not yet been characterized. Following a single oral dose administration of 300 mg radiolabeled berotralstat, about 34% of the total plasma radioactivity accounted for the unchanged drug while about eight detectable metabolites accounted for 1.8 to 7.8% of the total radioactivity.
Following a single oral dose administration of 300 mg radiolabeled berotralstat, the median elimination half-life of berotralstat was approximately 93 hours, ranging from 39 to 152 hours.
Hereditary angioedema (HAE) is a rare genetic disorder associated with severe swelling of the skin and upper airway. It is caused by mutations in the regulatory or coding regions of the gene that encodes C1 inhibitor (SERPING1), which result in either a deficiency (type I) or dysfunction (type II) of C1 inhibitor (C1 esterase inhibitor, C1-INH). C1 inhibitor is a serine protease inhibitor that normally regulates bradykinin production by covalently binding to and inactivating plasma kallikrein. Plasma kallikrein is a protease that cleaves high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK). During HAE attacks, the levels of plasma kallikrein fall, leading to the cleavage of high-molecular-weight-kininogen and the release of bradykinin, a potent vasodilator that increases vascular permeability. Bradykinin plays a major role in promoting edema and pain associated with HAE. Patients with HAE cannot properly regulate plasma kallikrein activity due to the deficiency or dysfunction of a serum inhibitor of C1 inhibitor, leading to uncontrolled increases in plasma kallikrein activity and recurrent angioedema attacks. Berotralstat is a potent inhibitor of plasma kallikrein that works by binding to plasma kallikrein and blocking its proteolytic activity, thereby controlling excess bradykinin generation.
Details:
Orladeyo (berotralstat), plasma kallikrein inhbitor, which is being evaluated for the treatment in pediatric patients with hereditary angioedema aged 2 to <12 years.
Lead Product(s): Berotralstat Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 24, 2025
Lead Product(s) : Berotralstat Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
BioCryst Announces Positive Results from APeX-P Trial for Orladeyo (berotralstat)
Details : Orladeyo (berotralstat), plasma kallikrein inhbitor, which is being evaluated for the treatment in pediatric patients with hereditary angioedema aged 2 to <12 years.
Product Name : Orladeyo
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 24, 2025
Details:
Orladeyo (berotralstat), plasma kallikrein inhbitor, is the first oral therapy designed to prevent hereditary angioedema attacks in patients aged 12 and older.
Lead Product(s): Berotralstat Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 12, 2025
Lead Product(s) : Berotralstat Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
BioCryst Launches ORLADEYO® (berotralstat) in Portugal
Details : Orladeyo (berotralstat), plasma kallikrein inhbitor, is the first oral therapy designed to prevent hereditary angioedema attacks in patients aged 12 and older.
Product Name : Orladeyo
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 12, 2025
Details:
Orladeyo (berotralstat), plasma kallikrein inhbitor, is the first oral therapy designed to prevent hereditary angioedema attacks in patients aged 12 and older.
Lead Product(s): Berotralstat Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2024
Lead Product(s) : Berotralstat Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
BioCryst Launches ORLADEYO® (berotralstat) in Ireland
Details : Orladeyo (berotralstat), plasma kallikrein inhbitor, is the first oral therapy designed to prevent hereditary angioedema attacks in patients aged 12 and older.
Product Name : Orladeyo
Product Type : Small molecule
Upfront Cash : Not Applicable
November 18, 2024
Details:
Orladeyo (berotralstat), plasma kallikrein inhbitor, is the first oral therapy designed to prevent hereditary angioedema attacks in patients aged 12 and older.
Lead Product(s): Berotralstat Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 09, 2024
Lead Product(s) : Berotralstat Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Pint Pharma Approves ORLADEYO® for HAE Prevention in Peru
Details : Orladeyo (berotralstat), plasma kallikrein inhbitor, is the first oral therapy designed to prevent hereditary angioedema attacks in patients aged 12 and older.
Product Name : Orladeyo
Product Type : Small molecule
Upfront Cash : Not Applicable
July 09, 2024
Details:
Orladeyo (berotralstat), an inhibitor of plasma kallikrein, is the first and only oral therapy specifically designed to prevent hereditary angioedema attacks in patients aged 12 and older.
Lead Product(s): Berotralstat Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: BioCryst Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2024
Lead Product(s) : Berotralstat Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : BioCryst Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Pint Pharma Approves ORLADEYO® (berotralstat) for HAE Prevention in Mexico for Ages 12+
Details : Orladeyo (berotralstat), an inhibitor of plasma kallikrein, is the first and only oral therapy specifically designed to prevent hereditary angioedema attacks in patients aged 12 and older.
Product Name : Orladeyo
Product Type : Small molecule
Upfront Cash : Not Applicable
May 13, 2024
Details:
Orladeyo (berotralstat), an inhibitor of plasma kallikrein, is the first and only oral therapy specifically designed to prevent hereditary angioedema attacks in patients aged 12 and older.
Lead Product(s): Berotralstat Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: BioCryst Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2024
Lead Product(s) : Berotralstat Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : BioCryst Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Pint Pharma Approves ORLADEYO (berotralstat) for HAE Prevention in Brazil for Ages 12+
Details : Orladeyo (berotralstat), an inhibitor of plasma kallikrein, is the first and only oral therapy specifically designed to prevent hereditary angioedema attacks in patients aged 12 and older.
Product Name : Orladeyo
Product Type : Small molecule
Upfront Cash : Not Applicable
April 16, 2024
Details:
Argentina's regulatory body approved the drug product, Orladeyo® (berotralstat), a plasma kallikrein inhibitor, is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older.
Lead Product(s): Berotralstat Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2023
Lead Product(s) : Berotralstat Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
BioCryst Announces Approval of ORLADEYO® (berotralstat) by the National Administration of Drugs, ...
Details : Argentina's regulatory body approved the drug product, Orladeyo® (berotralstat), a plasma kallikrein inhibitor, is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older.
Product Name : Orladeyo
Product Type : Small molecule
Upfront Cash : Not Applicable
November 29, 2023
Details:
Orladeyo (berotralstat) is an oral, once-daily, plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years and older.
Lead Product(s): Berotralstat Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 21, 2023
Lead Product(s) : Berotralstat Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
BioCryst Launches ORLADEYO® (berotralstat) in Spain
Details : Orladeyo (berotralstat) is an oral, once-daily, plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients 12 years and older.
Product Name : Orladeyo
Product Type : Small molecule
Upfront Cash : Not Applicable
November 21, 2023
Details:
Orladeyo® (berotralstat) is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older. One capsule per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
Lead Product(s): Berotralstat Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2023
Lead Product(s) : Berotralstat Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
INESSS Recommends Public Reimbursement for BioCryst’s ORLADEYO® (berotralstat) for the Preventi...
Details : Orladeyo® (berotralstat) is the first and only oral therapy designed to prevent attacks of HAE in adult and pediatric patients 12 years and older. One capsule per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
Product Name : Orladeyo
Product Type : Small molecule
Upfront Cash : Not Applicable
September 18, 2023
Details:
Under the collaboration, Er-Kim Pharmaceuticals will commercialize Orladeyo (berotralstat), the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older, in Turkey.
Lead Product(s): Berotralstat Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Orladeyo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: BioCryst Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration July 19, 2023
Lead Product(s) : Berotralstat Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : BioCryst Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Collaboration
BioCryst Selects Er-Kim Pharmaceuticals as Commercial Partner for ORLADEYO® (berotralstat) in Tur...
Details : Under the collaboration, Er-Kim Pharmaceuticals will commercialize Orladeyo (berotralstat), the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older, in Tur...
Product Name : Orladeyo
Product Type : Small molecule
Upfront Cash : Undisclosed
July 19, 2023
Regulatory Info : RX
Registration Country : USA
Brand Name : ORLADEYO
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 110MG BASE
Packaging :
Approval Date : 2020-12-03
Application Number : 214094
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ORLADEYO
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 150MG BASE
Packaging :
Approval Date : 2020-12-03
Application Number : 214094
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Switzerland
Brand Name : Orladeyo
Dosage Form : Kaps
Dosage Strength : 150mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Global Sales Information
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Patents & EXCLUSIVITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Berotralstat API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Berotralstat manufacturer or Berotralstat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Berotralstat manufacturer or Berotralstat supplier.
PharmaCompass also assists you with knowing the Berotralstat API Price utilized in the formulation of products. Berotralstat API Price is not always fixed or binding as the Berotralstat Price is obtained through a variety of data sources. The Berotralstat Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Berotralstat Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Berotralstat Hydrochloride, including repackagers and relabelers. The FDA regulates Berotralstat Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Berotralstat Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Berotralstat Hydrochloride supplier is an individual or a company that provides Berotralstat Hydrochloride active pharmaceutical ingredient (API) or Berotralstat Hydrochloride finished formulations upon request. The Berotralstat Hydrochloride suppliers may include Berotralstat Hydrochloride API manufacturers, exporters, distributors and traders.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Berotralstat Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Berotralstat Hydrochloride API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Berotralstat Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Berotralstat Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Berotralstat Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Berotralstat Hydrochloride suppliers with NDC on PharmaCompass.
Berotralstat Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Berotralstat Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Berotralstat Hydrochloride GMP manufacturer or Berotralstat Hydrochloride GMP API supplier for your needs.
A Berotralstat Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Berotralstat Hydrochloride's compliance with Berotralstat Hydrochloride specifications and serves as a tool for batch-level quality control.
Berotralstat Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Berotralstat Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Berotralstat Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Berotralstat Hydrochloride EP), Berotralstat Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Berotralstat Hydrochloride USP).