# US 10,870,021 B2 · Ambrisentan for use in the treatment of acute renal failure

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- Number: US 10,870,021 B2
- Document ID: US10870021B2
- Status: Granted
- Kind: B2
- Application number: 16/084,340
- Filed: 2017-03-20
- Published: 2019-03-21
- Granted: 2020-12-22
- Earliest claimed: 2016-03-18
- Assignees: Noorik Biopharmaceuticals AG
- Applicants: Noorik Biopharmaceuticals AG
- Inventors: Iker Navarro; Satish Khanna
- Web page: https://patentgrep.com/patent/US10870021B2

## CPC

- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/00: Medicinal preparations characterised by special physical form {(nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 31/505: Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61P 13/12: of the kidneys
- A61K 31/00: Medicinal preparations containing organic active ingredients
- G01N 33/70: involving creatine or creatinine
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Ambrisentan and formulations thereof for use in the treatment and prevention of acute renal failure associated with renal vasoconstriction.

## Claims

### Claim 1

A method for treating a subject suffering from Hepatorenal Syndrome comprising administering an effective amount of ambrisentan to the subject, wherein ambrisentan is administered to the subject such that the plasma levels of ambrisentan are maintained below about 100 ng/ml, to treat the subject suffering from Hepatorenal Syndrome.

### Claim 2

A method for treating a subject suffering from Refractory Ascites comprising administering an effective amount of ambrisentan to the subject, wherein ambrisentan is administered to the subject such that the plasma levels of ambrisentan are maintained below about 100 ng/ml, to treat the subject suffering from Refractory Ascites.

### Claim 3

A method for treating a subject suffering from Dilutional Hyponatremia comprising administering an effective amount of ambrisentan to the subject, wherein ambrisentan is administered to the subject such that the plasma levels of ambrisentan are maintained below about 100 ng/ml, to treat the subject suffering from Dilutional Hyponatremia.

### Claim 4

A method for treating a subject suffering from a Hepatorenal Disorder and identifying a reduced renal function due to vasoconstriction comprising administering an effective amount of ambrisentan to the subject, wherein the renal function is determined before and after the administering, and wherein ambrisentan is administered to the subject such that the plasma levels of ambrisentan are maintained below about 100 ng/ml, to treat the subject suffering from the Hepatorenal Disorder and identify the reduced renal function.

### Claim 5

A method for treating a subject awaiting a liver transplant and identifying a reduced renal function due to vasoconstriction comprising administering an effective amount of ambrisentan to the subject, wherein the renal function is determined before and after treatment, and wherein ambrisentan is administered to the subject such that the plasma levels of ambrisentan are maintained below about 100 ng/ml, to treat the subject awaiting the liver transplant and identify the reduced renal function.

### Claim 6

A method for treating a subject awaiting a liver transplant and identifying a reduced renal function due to vasoconstriction comprising administering an effective amount of ambrisentan to the subject, wherein the renal function is determined before and after treatment, and in the absence of an improvement of renal function in the subject, the subject is eligible for a dual liver-kidney transplant, and wherein ambrisentan is administered to the subject such that the plasma levels of ambrisentan are maintained below about 100 ng/ml, to treat the subject awaiting the liver transplant and identify the reduced renal function.

### Claim 7 (depends on 4)

The method according to claim 4, wherein the Hepatorenal Disorder is Hepatorenal Syndrome.

### Claim 8 (depends on 6)

The method according to claim 6, wherein, in the absence of the improvement of renal function in the subject, the kidney will be transplanted in the subject.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the plasma levels of ambrisentan are maintained below about 50 ng/ml.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the plasma levels of ambrisentan are maintained below about 20 ng/ml.

### Claim 11 (depends on 2)

The method according to claim 2, wherein the plasma levels of ambrisentan are maintained below about 50 ng/ml.

### Claim 12 (depends on 2)

The method according to claim 2, wherein the plasma levels of ambrisentan are maintained below about 20 ng/ml.

### Claim 13 (depends on 3)

The method according to claim 3, wherein the plasma levels of ambrisentan are maintained below about 50 ng/ml.

### Claim 14 (depends on 3)

The method according to claim 3, wherein the plasma levels of ambrisentan are maintained below about 20 ng/ml.

### Claim 15 (depends on 4)

The method according to claim 4, wherein the plasma levels of ambrisentan are maintained below about 50 ng/ml.

### Claim 16 (depends on 4)

The method according to claim 4, wherein the plasma levels of ambrisentan are maintained below about 20 ng/ml.

### Claim 17 (depends on 5)

The method according to claim 5, wherein the plasma levels of ambrisentan are maintained below about 50 ng/ml.

### Claim 18 (depends on 5)

The method according to claim 5, wherein the plasma levels of ambrisentan are maintained below about 20 ng/ml.

### Claim 19 (depends on 6)

The method according to claim 6, wherein the plasma levels of ambrisentan are maintained below about 50 ng/ml.

### Claim 20 (depends on 6)

The method according to claim 6, wherein the plasma levels of ambrisentan are maintained below about 20 ng/ml.
