Wednesday, July 8, 2026

Drug profile · INN

sepiapterin

sepiapterin (SEPHIENCE) is an FDA-listed pharmaceutical active ingredient. Associated with PTC THERAPEUTICS, INC.. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Alimentary tract and metabolism (A16) A16AX28
US status approved
Patents linked 20
Pipeline programs 2
News articles 0
Drug details — sepiapterin
US status
approved
Class
Alimentary tract and metabolism (A16)
Route
ORAL
Patents
20
Programs
2
Data quality
0.89

Quick answer

sepiapterin (SEPHIENCE) is an FDA-listed pharmaceutical active ingredient. Associated with PTC THERAPEUTICS, INC.. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN sepiapterin
Brand SEPHIENCE
Therapeutic class Alimentary tract and metabolism (A16)
Route ORAL
Formulation POWDER
ATC code A16AX28

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. PTC923-PKU-401 Phase 3 · PTC THERAPEUTICS · Phenylketonuria
  2. Sepiapterin Phase 3 · PTC THERAPEUTICS · Phenylketonuria

Related & competitor drugs

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  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)
  1. US 12384789

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    granted
  2. US 12281083

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    granted
  3. US 12139499

    Heteroaryl compounds for treating Huntington's disease

    Expires Mon Nov 07 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 12103926

    Compounds for treating huntington's disease

    Expires Mon Sep 26 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 12023335

    Method for treating pancreatic cancer

    Expires Mon Jun 27 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11938101

    Polymorphic forms of (R)-2-hydroxy-2-methyl-4-(2,4,5-trimethyl-3,6-dioxocyclohexa-1,4-dienyl)butanamide

    Expires Mon Mar 21 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11858941

    Heterocyclic and heteroaryl compounds for treating Huntington's disease

    Expires Mon Dec 28 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 11786486

    Pharmaceutical compositions comprising 2,3,5-trimethyl-6-nonylcyclohexa-2,5-diene-1,4-dione

    Expires Mon Oct 12 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 11780839

    Compounds for treating Huntington's disease

    Expires Mon Oct 05 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 11753407

    Compounds for treating spinal muscular atrophy

    Expires Mon Sep 07 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 11746077

    2,3,5-trimethyl-6-nonylcyclohexa-2,5-diene-1,4-dione for suppressing and treating alpha-synucleinopathies, tauopathies, and other disorders

    Expires Mon Aug 31 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 11702646

    Methods for modulating RNA splicing

    Expires Mon Jul 13 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 11685746

    Heteroaryl compounds for treating Huntington's disease

    Expires Mon Jun 22 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 11667596

    2,3,5-trimethyl-6-nonylcyclohexa-2,5-diene-1,4-dione for suppressing and treating alpha-synucleinopathies, tauopathies, and other disorders

    Expires Mon Jun 01 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 11638706

    Methods for treating Huntington's disease

    Expires Mon Apr 27 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 11613538

    Method of inhibiting or reducing a viral infection

    Expires Mon Mar 23 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 11608501

    Methods for modifying RNA splicing

    Expires Mon Mar 16 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 11602567

    Methods for modulating RNA splicing

    Expires Mon Mar 09 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 11407753

    Compounds for treating Huntington's disease

    Expires Mon Aug 04 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 11395822

    Methods for treating Huntington's disease

    Expires Mon Jul 21 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is sepiapterin?

sepiapterin (SEPHIENCE) is an FDA-listed pharmaceutical active ingredient. Associated with PTC THERAPEUTICS, INC.. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for sepiapterin?

SEPHIENCE is a marketed brand name for sepiapterin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of sepiapterin?

sepiapterin has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.