You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 15, 2025

Claims for Patent: 12,138,245

✉ Email this page to a colleague

« Back to Dashboard

Summary for Patent: 12,138,245

Title:	Methods for treating heterotopic ossification
Abstract:	The invention features dosing regimens and pharmaceutical formulations for oral administration of palovarotene. The dosing regimens can reduce heterotopic ossification, reduce the number of flare-ups, and/or reduce the severity of flare-ups in subjects suffering from fibrodysplasia ossificans progressiva.
Inventor(s):	Clarissa Desjardins, Donna Roy GROGAN, Jeffrey Neal PACKMAN, Mark Harnett
Assignee:	Clementia Pharmaceuticals Inc
Application Number:	US18/637,711
Patent Claims:	1. A method of reducing heterotopic ossification in a subject with fibrodysplasia ossificans progressiva, wherein the subject weighs from 10 to 20 kg, said method comprising: (i) during a period when the subject is not experiencing any flare-up symptom orally administering daily to the subject an amount of 2.5 mg of palovarotene, or a pharmaceutically acceptable salt thereof, and (ii) during a period when the subject is experiencing at least one flare-up symptom orally administering to the subject an amount of 10 mg of palovarotene, or a pharmaceutically acceptable salt thereof, daily for a period of 28 days, and after the period of 28 days, an amount of 5 mg of palovarotene, or a pharmaceutically acceptable salt thereof, daily for a period of at least 56 days. 2. The method of claim 1, wherein the 5 mg amount is administered daily for a period of 84 days. 3. The method of claim 1, wherein the 5 mg amount is administered daily for a period of 56 days. 4. The method of claim 1, wherein the 5 mg amount is administered daily for a period of 56 days, and for an additional 28 days if the subject continues to experience at least one flare-up symptom. 5. The method of claim 1, wherein the 5 mg amount is administered daily for a period of 112 days. 6. The method of claim 1, wherein the at least one flare-up symptom is chosen from swelling, pain, erythema, warmth, stiffness, and decreased range of motion. 7. A method of reducing heterotopic ossification in a subject with fibrodysplasia ossificans progressiva, wherein the subject weighs from 20 kg to 40 kg, said method comprising: (i) during a period when the subject is not experiencing any flare-up symptom orally administering daily to the subject an amount of 3 mg of palovarotene, or a pharmaceutically acceptable salt thereof, and (ii) during a period when the subject is experiencing at least one flare-up symptom orally administering to the subject an amount of 12.5 mg of palovarotene, or a pharmaceutically acceptable salt thereof, daily for a period of 28 days, and after the period of 28 days, an amount of 6 mg of palovarotene, or a pharmaceutically acceptable salt thereof, daily for a period of at least 56 days. 8. The method of claim 7, wherein the 6 mg amount is administered daily for a period of 84 days. 9. The method of claim 7, wherein the 6 mg amount is administered daily for a period of 56 days. 10. The method of claim 7, wherein the 6 mg amount is administered daily for a period of 56 days, and for an additional 28 days if the subject continues to experience at least one flare-up symptom. 11. The method of claim 7, wherein the 6 mg amount is administered daily for a period of 112 days. 12. The method of claim 7, wherein the at least one flare-up symptom is chosen from swelling, pain, erythema, warmth, stiffness, and decreased range of motion. 13. A method of reducing heterotopic ossification in a subject with fibrodysplasia ossificans progressiva, wherein the subject weighs from 40 kg to 60 kg, said method comprising: (i) during a period when the subject is not experiencing any flare-up symptom orally administering daily to the subject an amount of 4 mg of palovarotene, or a pharmaceutically acceptable salt thereof, and (ii) during a period when the subject is experiencing at least one flare-up symptom orally administering to the subject an amount of 15 mg of palovarotene, or a pharmaceutically acceptable salt thereof, daily for a period of 28 days, and after the period of 28 days, an amount of 7.5 mg of palovarotene, or a pharmaceutically acceptable salt thereof, daily for a period of at least 56 days. 14. The method of claim 13, wherein the 7.5 mg amount is administered daily for a period of 84 days. 15. The method of claim 13, wherein the 7.5 mg amount is administered daily for a period of 56 days. 16. The method of claim 13, wherein the 7.5 mg amount is administered daily for a period of 56 days, and for an additional 28 days if the subject continues to experience at least one flare-up symptom. 17. The method of claim 13, wherein the 7.5 mg amount is administered daily for a period of 112 days. 18. The method of claim 13, wherein the at least one flare-up symptom is chosen from swelling, pain, erythema, warmth, stiffness, and decreased range of motion.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.