Sepiapterin 1000 mg, 250 mg Suppliers & Bulk Manufacturers
Available Forms: Tablets / oral powder
Available Strengths: 1000 mg, 250 mg
Reference Brands: Sephience (USA/EU)
Category: Orphan Drugs
Sepiapterin is a Orphan Drugs product available as Tablets / oral powder in strengths 1000 mg, 250 mg. It corresponds to the reference brand Sephience (USA/EU). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.
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Product Description:
Sepiapterin is a phenylalanine hydroxylase activator used for the treatment of hyperphenylalaninemia, including phenylketonuria (PKU). Marketed under the brand name Sephience, Sepiapterin supports metabolic control in patients who are unable to adequately process phenylalanine due to enzymatic deficiency. It works by enhancing the activity of phenylalanine hydroxylase, a key enzyme responsible for converting phenylalanine into tyrosine, thereby helping to reduce elevated blood phenylalanine levels.
Sepiapterin is a naturally occurring metabolite synthesized in the human body and serves as a biochemical precursor in the salvage pathway leading to the formation of tetrahydrobiopterin (BH4). BH4 is an essential cofactor required for the normal metabolism of phenylalanine and plays a critical role in the synthesis of neurotransmitter precursors derived from tyrosine and tryptophan, including dopamine and serotonin.
By restoring metabolic balance and improving enzymatic function, Sepiapterin provides a targeted therapeutic option for patients with disorders of phenylalanine metabolism. It is intended for long-term management and may be used alongside dietary control and other supportive treatments to achieve optimal metabolic outcomes.
How Sepiapterin is supplied today, and licensing ahead of patent expiry
Where sepiapterin is approved
Checked 3 Oct 2026| Market | Status | Brand · regulator · date |
|---|---|---|
| European Union | Approved | Sephience · European Commission · Jun 2025 |
| United States | Approved | Sephience · FDA · Jul 2025 |
| Generic / biosimilar | None | None approved as of the check date |
Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →
Frequently Asked Questions
Sepiapterin is used for the treatment of phenylketonuria (PKU) to help lower and control elevated blood phenylalanine levels.
Sepiapterin is a synthetically manufactured compound that serves as a biochemical precursor to tetrahydrobiopterin (BH4).
The trade name of Sepiapterin is Sephience.
Sepiapterin (Sephience) is developed and manufactured by PTC Therapeutics.
The generic name of Sephience is Sepiapterin dihydrochloride.
The brand name of Sepiapterin is Sephience.
Sepiapterin is manufactured at PTC Therapeutics’ approved pharmaceutical manufacturing facilities, operating under international GMP and regulatory standards.
Sephience (Sepiapterin) is developed and sold by PTC Therapeutics. PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.
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