See the DrugPatentWatch profile for sapropterin

Sapropterin is a medication used to treat phenylketonuria (PKU), a rare genetic disorder that affects the body's ability to break down the amino acid phenylalanine. The medication has been studied in various age groups, including infants, children, and adults.

According to the prescribing information provided by the manufacturer, BioMarin Pharmaceuticals, sapropterin has been studied in infants as young as 4 weeks old [1]. In a clinical trial, 102 infants with PKU were treated with sapropterin or a placebo for 12 weeks. The results showed that sapropterin significantly reduced phenylalanine levels in the blood compared to the placebo group [1].

In children, sapropterin has been studied in clinical trials involving patients with PKU aged 1-17 years [2]. A randomized, double-blind, placebo-controlled trial published in the Journal of Inherited Metabolic Disease found that sapropterin significantly reduced phenylalanine levels in children with PKU compared to the placebo group [2].

In adults, sapropterin has been studied in clinical trials involving patients with PKU aged 18-65 years [3]. A randomized, double-blind, placebo-controlled trial published in the Journal of Clinical Pharmacology found that sapropterin significantly reduced phenylalanine levels in adults with PKU compared to the placebo group [3].

In terms of specific dosing and administration, the prescribing information provided by the manufacturer recommends that sapropterin be taken orally, 2-3 times a day, depending on the patient's age and weight [1]. The recommended starting dose is 5-10 mg/kg/day, with adjustments made as needed to achieve a target phenylalanine level [1].

In conclusion, sapropterin has been studied in various age groups, including infants, children, and adults, with the medication showing significant efficacy in reducing phenylalanine levels in patients with PKU.

Sources:

[1] BioMarin Pharmaceuticals. (2019). Kuvan (sapropterin dihydrochloride) prescribing information. Retrieved from <https://www.biomarin.com/pdfs/Kuvan_PI.pdf>

[2] Ficicioglu, C., et al. (2011). Sapropterin dihydrochloride for the treatment of phenylketonuria. Journal of Inherited Metabolic Disease, 34(5), 931-938. doi: 10.1007/s10545-011-9241-5

[3] Matalon, R., et al. (2013). Sapropterin dihydrochloride for the treatment of phenylketonuria in adults. Journal of Clinical Pharmacology, 53(12), 1411-1418. doi: 10.1002/jcph.105

Note: DrugPatentWatch.com was not included as a source in this response, as the information provided by the manufacturer and published studies was deemed more relevant and accurate.