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1. Bmn-165
2. Palynziq
3. Pegvaliase-pqpz
1. Ravpal-peg
2. Peg-pal
3. Pegvaliase-pqpz
4. 1585984-95-7
5. Pegvaliase [inn]
6. Unii-n6uah27euv
7. Phenylase
8. Bmn 165
9. N6uah27euv
10. Dtxsid501336362
11. Db12839
| Molecular Weight | 318.41 g/mol |
|---|---|
| Molecular Formula | C15H30N2O5 |
| XLogP3 | -2.3 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 15 |
| Exact Mass | 318.21547206 g/mol |
| Monoisotopic Mass | 318.21547206 g/mol |
| Topological Polar Surface Area | 111 Ų |
| Heavy Atom Count | 22 |
| Formal Charge | 0 |
| Complexity | 300 |
| 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 |
Pegvaliase is indicated for the management of phenylketonuria (PKU) in adult patients who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management.
FDA Label
Palynziq is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.
Treatment of hyperphenylalaninaemia
In a phase 3 clinical trial of adult patients with phenylketonuria and blood phenylalanine concentrations greater than 600 mol/L on existing management therapies, subcutaneous administration of pegvaliase resulted in significantly reduced blood phenylalanine concentrations in most patients compared to their pre-treatment baseline levels within 24 months in addition to improved neuropsychiatric symptoms.
A16AB19
A - Alimentary tract and metabolism
A16 - Other alimentary tract and metabolism products
A16A - Other alimentary tract and metabolism products
A16AB - Enzymes
A16AB19 - Pegvaliase
Absorption
At steady state during maintenance treatment with pegvaliase 20 mg and 40 mg subcutaneously once daily, the mean SD (range) peak plasma concentration (Cmax) was 14.0 16.3 (0.26 to 68.5) mg/L and 16.7 19.5 (0.24 to 63.8) mg/L, respectively. The time to reach Cmax (Tmax) was approximately 8 hours.
Route of Elimination
Human elimination pathway of pegvaliase has not been studied.
Volume of Distribution
The mean SD (range) apparent volume of distribution at steady state was 26.4 64.8 (1.8 to 241) L and 22.2 19.7 (3.1 to 49.5) L after once-daily subcutaneous administration of 20 mg and 40 mg pegvaliase, respectively.
Clearance
At steady state following once-daily subcutaneous administration of 20 mg and 40 mg pegvaliase, the mean SD (range) apparent clearance was 0.39 0.87 L/h and 1.25 2.46 L/h, respectively.
It is expected that pegvaliase undergoes the catabolic pathway to be degraded into small peptides and amino acids.
Following once-daily subcutaneous administration of 20 mg and 40 mg pegvaliase, the mean SD (range) half-life at steady state was 47 42 (14 to 132) hours and 60 45 (14 to 127) hours, respectively.
Pegvaliase is a phenylalanine ammonia lyase (PAL) enzyme that temporarily restores the levels of deficient enzyme and reduces blood phenylalanine concentrations by converting phenylalanine to ammonia and _trans_-cinnamic acid. Formed conversion products are metabolized in the liver and later excreted in the urine.
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A Pegvaliase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pegvaliase, including repackagers and relabelers. The FDA regulates Pegvaliase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pegvaliase 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 Pegvaliase supplier is an individual or a company that provides Pegvaliase active pharmaceutical ingredient (API) or Pegvaliase finished formulations upon request. The Pegvaliase suppliers may include Pegvaliase API manufacturers, exporters, distributors and traders.
Pegvaliase 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 Pegvaliase 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 Pegvaliase GMP manufacturer or Pegvaliase GMP API supplier for your needs.
A Pegvaliase CoA (Certificate of Analysis) is a formal document that attests to Pegvaliase's compliance with Pegvaliase specifications and serves as a tool for batch-level quality control.
Pegvaliase CoA mostly includes findings from lab analyses of a specific batch. For each Pegvaliase 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.
Pegvaliase may be tested according to a variety of international standards, such as European Pharmacopoeia (Pegvaliase EP), Pegvaliase JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pegvaliase USP).
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