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- Nachgewiesen in: USPTO Patent Grants
- Sprachen: English
- Patent Number: 11992,479
- Publication Date: May 28, 2024
- Appl. No: 17/052359
- Application Filed: May 02, 2019
- Assignees: DAMIAN PHARMA AG (Walchwil, CH)
- Claim: 1. A method of treating a disease or disorder selected from primary aldosteronism and secondary aldosteronism in human a subject in need thereof, the method comprising orally administering once daily to said subject a therapeutically effective amount of a composition comprising 4 mg or 8 mg of a compound which is R)-(+)-5-(p-cyanophenyl)-5,6,7,8-tetrahydroimidazo[1,5-a]pyridine dihydrogen phosphate, wherein said compound has an enantiomeric excess (ee) of the (R) form higher than or equal to 99%.
- Claim: 2. The method according to claim 1 , wherein an elimination half-life (T 1/2) of said compound upon administration of one 4mg or 8mg daily dose to the subject is longer than 8h, as measured in a blood sample of the subject obtained at 8, 12, 16 or 24 hours post-dose.
- Claim: 3. The method according to claim 1 , wherein said (R)-(+)-5-(p-cyanophenyl)-5,6,7,8-tetrahydroimidazolium[1,5-a]pyridine dihydrogen phosphate is a crystalline form I of (R)-(+)-5-(p-cyanophenyl)-5,6,7,8-tetrahydroimidazolium [1,5-a]pyridine dihydrogen phosphate, wherein said crystalline form I has an X-ray powder diffraction pattern comprising the following 20 values measured using CuKα radiation: 19.504; 21.919 and 24.159, wherein each peak may vary by ±0.5.
- Claim: 4. The method according to claim 1 , wherein said disease or disorder is primary aldosteronism.
- Claim: 5. The method of claim 1 , wherein said disease or disorder is secondary aldosteronism.
- Claim: 6. The method according to claim 1 , wherein said compound has an enantiomeric excess (ee) of the (R) form higher than or equal to 99.5%.
- Claim: 7. The method according to claim 1 , wherein said compound has an enantiomeric excess (ee) of the (R) form higher than or equal to 99.8%.
- Claim: 8. The method according to claim 1 , wherein said compound has an enantiomeric excess (ee) of the (R) form higher than or equal to 99.9%.
- Claim: 9. The method according to claim 1 , wherein said disease or disorder is primary aldosteronism, and wherein said composition comprises 8 mg of the compound.
- Claim: 10. The method according to claim 1 , wherein said disease or disorder is secondary aldosteronism, and wherein said composition comprises 8 mg of the compound.
- Claim: 11. The method according to claim 1 , wherein said disease or disorder is primary aldosteronism, and wherein said composition comprises 4 mg of the compound.
- Claim: 12. The method according to claim 1 , wherein said disease or disorder is secondary aldosteronism, and wherein said composition comprises 4 mg of the compound.
- Claim: 13. A method of treating primary aldosteronism in a human subject in need thereof, the method comprising orally administering to the subject 4 mg of the compound (R)-(+)-5-(p-cyanophenyl)-5,6,7,8-tetrahydroimidazolium[1,5-a]pyridine dihydrogen phosphate, once daily, wherein said compound has an enantiomeric excess (ee) of the (R) form higher than or equal to 99%.
- Claim: 14. A method of treating primary aldosteronism in a human subject in need thereof, the method comprising orally administering to the subject 8 mg of the compound (R)-(+)-5-(p-cyanophenyl)-5,6,7,8-tetrahydroimidazolium[1,5-a]pyridine dihydrogen phosphate, once daily, wherein said compound has an enantiomeric excess (ee) of the (R) form higher than or equal to 99%.
- Claim: 15. The method of claim 13 , wherein the human subject is a pediatric patient.
- Claim: 16. The method of claim 13 , wherein the human subject is a woman of child bearing potential.
- Claim: 17. The method of claim 14 , wherein the human subject is a pediatric patient.
- Claim: 18. The method of claim 14 , wherein the human subject is a woman of child bearing potential.
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- Primary Examiner: Rozof, Timothy R
- Attorney, Agent or Firm: MEDLER FERRO WOODHOUSE & MILLS PLLC
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