IP Library › Granted Patent US 12,697,315
Granted Patent B2
US 12,697,315 · App. 19/420,084 · Granted Aug 4, 2026

Treatment for interstitial lung disease

Inventors: Leigh Peterson (Hillsborough, NC); Peter Smith (Durham, NC); Chunqin Deng (Chapel Hill, NC)
Assignee: United Therapeutics Corporation
A61K31/192A61K9/0075A61K9/0078A61P9/12
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Quick Facts
Patent No.
US 12,697,315
App. No.
19/420,084
Filed
Dec 15, 2025
Granted
Aug 4, 2026
Kind
B2
Examiner
WARD, PAUL V
Art Unit
1622
USPC
514/569
Abstract

Methods of treating of interstitial lung disease, reducing pulmonary function decline in a subject with interstitial lung disease (ILD), and increasing forced vital capacity (FVC) in a subject suffering from ILD are provided, wherein the methods include administration of treprostinil.

Claims (21)

1 . A method of treating pulmonary fibrosis comprising administering by inhalation to a patient having pulmonary fibrosis an effective amount of at least 15 micrograms up to a maximum tolerated dose of treprostinil or a pharmaceutically acceptable salt thereof in a single administration event that comprises at least 6 micrograms per breath.

2 . The method of claim 1 , wherein the pulmonary fibrosis is idiopathic pulmonary fibrosis.

3 . The method of claim 1 , wherein said administering provides a statistically significant increase of a 6 minutes walk distance in the patient after 8 weeks of the administering.

4 . The method of claim 1 , wherein said administering provides a statistically significant increase of a 6 minutes walk distance in the patient after 12 weeks of the administering.

5 . The method of claim 1 , wherein said administering provides a statistically significant increase of a 6 minutes walk distance in the patient after 16 weeks of the administering.

6 . The method of claim 1 , wherein said administering increases time to exacerbation of underlying lung disease.

7 . The method of claim 1 , wherein the inhalation is performed with a nebulizer.

8 . The method of claim 1 , wherein the inhalation is performed with a dry powder inhaler.

9 . The method of claim 1 , wherein the patient receives up to 4 administration events of at least 15 micrograms up to a maximum tolerated dose per day.

10 . The method of claim 1 , wherein the effective amount is at least 15 micrograms up to 100 micrograms.

11 . The method of claim 9 , wherein each administration event is an effective amount of at least 15 micrograms up to 100 micrograms.

12 . The method of claim 1 , wherein the effective amount is at least about 18 micrograms up to a maximum tolerated dose of treprostinil or a pharmaceutically acceptable salt thereof in a single administration event that comprises at least 6 micrograms per breath.

13 . The method of claim 12 , wherein the effective amount is from about 18 micrograms to about 72 micrograms of treprostinil or a pharmaceutically acceptable salt thereof in a single administration event that comprises at least 6 micrograms per breath.

14 . The method of claim 12 , wherein said administering provides a statistically significant increase in a forced vital capacity (FVC) value of the patient after 8 weeks of the administering compared to an FVC value of a pulmonary fibrosis patient treated with a placebo.

15 . The method of claim 12 , wherein said administering provides a statistically significant increase in a FVC value of the patient after 16 weeks of the administering compared to an FVC value of a pulmonary fibrosis patient treated with a placebo.

16 . The method of claim 14 , wherein the patient is administered the single administration event four times per day.

17 . The method of claim 15 , wherein the patient is administered the single administration event four times per day.

18 . The method of claim 16 , wherein the inhalation is performed with a nebulizer.

19 . The method of claim 16 , wherein the inhalation is performed with a dry powder inhaler.

20 . The method of claim 17 , wherein the inhalation is performed with a nebulizer.

21 . The method of claim 17 , wherein the inhalation is performed with a dry powder inhaler.

Continuity (6)
Division 18586056 · Feb 23, 2024
Continuation 18219944 · Jul 10, 2023
Continuation 17233061 · Apr 16, 2021
Provisional Application 63160611 · Mar 12, 2021
Provisional Application 63011810 · Apr 17, 2020
Related Publication 20260102366A1 · Apr 16, 2026
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