# US 11,026,954 B2 · 3-beta-hydroxy-5-alpha-pregnan-20-one for use in medical treatment

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- Number: US 11,026,954 B2
- Document ID: US11026954B2
- Status: Granted
- Kind: B2
- Application number: 16/484,940
- Filed: 2018-09-02
- Published: 2019-11-28
- Granted: 2021-06-08
- Earliest claimed: 2017-02-10
- Assignees: Asarina Pharma AB
- Applicants: Asarina Pharma AB
- Inventors: Torbjörn Bäckström
- Web page: https://patentgrep.com/patent/US11026954B2

## CPC

- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61P 25/14: for treating abnormal movements, e.g. chorea, dyskinesia
- A61K 31/136: having the amino group directly attached to the aromatic ring, e.g. benzeneamine
- A61K 31/138: Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine (atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377)
- A61K 31/15: Oximes (>C=N—O—); Hydrazines (>N—N<); Hydrazones (>N—N=) {; Imines (C—N=C)}
- A61K 31/155: Amidines ([IMAGE cpc-sch-A61K-1029.gif]), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
- A61K 31/343: condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
- A61K 31/4168: having a nitrogen attached in position 2, e.g. clonidine
- A61K 31/451: having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
- A61K 31/454: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
- A61K 31/496: Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/5415: ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
- A61K 31/55: having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K 31/57: substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048})
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- 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

## Abstract

The present invention provides the steroid compound 3beta-hydroxy-5alpha-pregnan-20-one for use in treatment of Tourette's syndrome, obsessive compulsive disorder and/or gambling disorder, as well as methods for treating said disorders and pharmaceutical compositions for use in treatment of said disorders.

## Claims

### Claim 1

A method of treating Tourette's syndrome, obsessive compulsive disorder and/or gambling disorder, comprising administering a pharmaceutically effective amount of 3beta-hydroxy-5alpha-pregnan-20-one, to a patient in need thereof.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the patient suffers from Tourette's syndrome, and 3beta-hydroxy-5alpha-pregnan-20-one is administered in an amount effective to treat the patient's Tourette's syndrome.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the patient suffers from obsessive compulsive disorder, and 3beta-hydroxy-5alpha-pregnan-20-one is administered in an amount effective to treat the patient's obsessive-compulsive disorder.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the patient suffers from gambling disorder, and 3beta-hydroxy-5alpha-pregnan-20-one is administered in an amount effective to treat the patient's gambling disorder.

### Claim 5 (depends on 1)

The method according to claim 1, wherein 3beta-hydroxy-5alpha-pregnan-20-one is administered in combination with at least one additional active compound, selected from the group consisting of serotonin reuptake inhibitors (SSRI), 5alpha-reducase blockers, typical and atypical neuroleptics, antihypertensive agents, tricyclic antidepressants, and opioid antagonists.

### Claim 6 (depends on 5)

The method according to claim 5 wherein the serotonin reuptake inhibitors (SSRI) are selected from the group consisting of citalopram, ecitalopram, fluoxetine, sertraline, and fluvoxamine.

### Claim 7 (depends on 5)

The method according to claim 5 wherein the 5alpha-reducase blockers are selected from the group consisting of finasteride or dutasteride.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the 3beta-hydroxy-5alpha-pregnan-20-one is administered in a pharmaceutical composition comprising 3beta-hydroxy-5alpha-pregnan-20-one and one or more pharmaceutically acceptable carriers, excipients and/or diluents.

### Claim 9 (depends on 5)

The method according to claim 5, wherein the typical and atypical neuroleptics are selected from the group consisting of risperdone, ziprasidone, haloperidol, pimozide and fluphenazine.

### Claim 10 (depends on 5)

The method according to claim 5, wherein the antihypertensive agents are selected from the group consisting of clonidine and guanfacine.

### Claim 11 (depends on 5)

The method according to claim 5, wherein the tricyclic antidepressant is clomipramine.

### Claim 12 (depends on 1)

The method according to claim 1, wherein said 3beta-hydroxy-5-alpha-pregnan-20-one is administered intravenously, nasally, buccally, vaginally, rectally, subcutaneously, percutaneously or orally.

### Claim 13 (depends on 1)

The method according to claim 1, wherein said 3beta-hydroxy-5-alpha-pregnan-20-one is administered topically, locally, orally, parenterally or pulmonary.

### Claim 14 (depends on 1)

The method according to claim 1, wherein the 3beta-hydroxy-5-alpha-pregnan-20-one is in the form of a pharmaceutically acceptable salt, sulphate or ester.