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WO-2026096621-A1 - HAIR LOSS THERAPY

WO2026096621A1WO 2026096621 A1WO2026096621 A1WO 2026096621A1WO-2026096621-A1

Abstract

A pharmaceutical package for treating/preventing hair loss in a subject comprising a first pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, a second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5-α reductase inhibitor and a third pharmaceutical composition for oral administration, or either/and the first or second pharmaceutical composition, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth/hair loss prevention supplements. A single pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, a therapeutically effective or prophylactically effective amount of a 5-α reductase inhibitor and a therapeutically effective or prophylactically effective amount of one or more hair growth/hair loss prevention supplements. Methods of treating or preventing hair loss using the disclosed compositions and packages

Inventors

  • SINHA, Animesh

Assignees

  • NIRMANA BIO, INC.

Dates

Publication Date
20260507
Application Date
20251029
Priority Date
20241104

Claims (20)

  1. CLAIMS
  2. What is claimed is:
  3. 1. A pharmaceutical package for treating or preventing hair loss in a subject comprising: a first pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator; a second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5a-reductase inhibitor;
  4. and either or both a third pharmaceutical composition for oral administration and/or the first or the second pharmaceutical composition, or both, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth/hair loss prevention supplements.
  5. 2. The pharmaceutical package of claim 1, wherein the package comprises:
  6. a first pharmaceutical composition for oral administration of a therapeutically effective or prophylactically effective amount of minoxidil;
  7. a second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5a-reductase inhibitor;
  8. and either or both a third pharmaceutical composition for oral administration and/or the first or the second pharmaceutical composition, or both, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth/hair loss prevention supplements.
  9. 3. The pharmaceutical package of claim 1 or claim 2, wherein the 5a-reductase inhibitor is finasteride.
  10. 4. The pharmaceutical package of claim 1 or claim 2, wherein the 5a-reductase inhibitor is dutasteride.
  11. 5. The pharmaceutical package of claims 1-4, wherein the minoxidil is about 2.5 mg to about 5 mg. 6. The pharmaceutical package of any of claims 1-3 or claim 5, wherein the finasteride is about 1 mg to about 5 mg.
  12. 7. The pharmaceutical package of any of claims 1-3 or 5-6, wherein the first composition comprises minoxidil at about 2.5 mg or 5 mg and the second composition comprises finasteride at about 2.5 mg.
  13. 8. The pharmaceutical package of any of claims 1-7, wherein either or both the third pharmaceutical composition and/or the first or the second pharmaceutical composition, or both, comprises one or more hair growth/hair loss prevention supplements selected from the group consisting of zinc, B-vitamins, tocotrienols, and saw palmetto. 9. The pharmaceutical package of claim 8, wherein the B-vitamins are one or more of vitamin B2 (Riboflavin), B3 (Niacin), B7 (Biotin), B9 (Folic acid), and B 12 (Cobalamin).
  14. 10. The pharmaceutical package of any of claims 1-6, wherein either or both the third pharmaceutical composition and/or the first or the second pharmaceutical composition, or both, comprises hair growth/hair loss prevention supplements selected from the group consisting of vitamin A, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B-6, vitamin B9, vitamin B-12, vitamin C, vitamin D3, vitamin D, vitamin E, vitamin K2, thiamin, biotin, niacin, folate, iron, iodine, zinc, copper, pantothenic acid, L-lysine, L-cysteine, L-methionine, L-proline, citrus bioflavonoids, horsetail extract, iodine from organic kelp, selenium, collagen, Indian ginseng (Ashwagandha), saw palmetto extract, curcumin, tocotrienol, tocopherol, hyaluronic acid, solubilized keratin, horsetail extract, resveratrol, black pepper, capsicum extract, calcium, a blend of shark and mollusk powder, millet seed extract, choline, inositol, tapioca syrup, cane sugar, dextrose, citric acid, medium-chain triglyceride (MCT) oil. Indian ginseng (ashwagandha), Acerola cherry, Amla, astaxanthin, ginseng, beta glucans, hyaluronic acid, kelp, reduced L-glutathione, L-theanine, magnesium chelate, wildcrafted rhodiola, wildcrafted saw palmetto, schisandra, shatavari, silica, silver ear mushroom, tocos, chelated zinc, cayenne, stinging nettle, turmeric, aloe vera leaf powder, brahmi extract (Bacopa mormieri), rosemary leaf powder, stinging nettle root powder, lutein, horsetail herb extract, piperine, hydroxypropyl methyl capsule, magnesium stearate and rice flour. 11. The pharmaceutical package of cany of claim 1-10, wherein any of the first, second or third pharmaceutical composition is in liquid form.
  15. 12. The pharmaceutical package of any of claims 1-11, wherein the hair loss is due to androgenic alopecia.
  16. 13. The pharmaceutical package of any of claims 1-3, wherein the hair loss is due to telogen effluvium and the first composition comprises about 25 mg to about 30 mg minoxidil.
  17. 14. The pharmaceutical package of any of claims 1-3, wherein the hair loss is due to alopecia areata and the first composition comprises about 3 mg to about 30 mg minoxidil.
  18. 15. The pharmaceutical package of any of claims 1-14, wherein the pharmaceutical package is a capsule, a tablet, a caplet, a blister pack, or a combi pack blister pack.
  19. 16. A single pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, a therapeutically effective or prophylactically effective amount of a 5o.-reductase inhibitor and a therapeutically effective or prophylactically effective amount of one or more hair growth/hair loss prevention supplements.
  20. 17. The single pharmaceutical composition of claim 16, wherein the 5a-reductase inhibitor is finasteride.

Description

HAIR LOSS THERAPY TECHNICAL FIELD [0001] This disclosure relates to therapy for hair loss. BACKGROUND [0002] Hair loss (alopecia) is a loss of hair from part of the head or body of a person, though typically at least the head is involved. Hair loss can be quite severe and results in baldness. Hair loss in some people causes psychological distress. But hair loss is a common problem. SUMMARY [0003] In one aspect, this disclosure provides a pharmaceutical package for treating or preventing hair loss in a subject comprising: a first pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator; a second pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5a-reductase inhibitor; and either or both a third pharmaceutical composition for oral administration and/or the first or the second pharmaceutical composition, or both, comprising a therapeutically effective or prophylactically effective amount of one or more hair growth/hair loss prevention supplements. [0004] In another aspect, this disclosure provides a single pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, a therapeutically effective or prophylactically effective amount of a 5a-reductase inhibitor, and a therapeutically effective or prophylactically effective amount of one or more hair growth/hair loss prevention supplements. [0005] In yet another aspect, this disclosure provides a method of treating or preventing hair loss in a subject in need thereof comprising administering the disclosed single composition or the disclosed compositions in the disclosed pharmaceutical package to a subject in need thereof. [0006] In another aspect, a single pharmaceutical composition for oral administration is provided. The composition comprises a therapeutically effective or prophylactically effective amount of minoxidil, or a similar antihypertensive vasodilator, and a 5-alpha reductase inhibitor for treating or preventing androgenic alopecia in a subject. [0007] In another aspect, this disclosure provides a method of treating or preventing androgenic alopecia in a subject in need thereof comprising administering by oral administration a disclosed single pharmaceutical composition to said subject. [0008] In another aspect, a pharmaceutical package is provided for treating or preventing androgen alopecia in a subject comprising a pharmaceutical composition for oral administration of a therapeutically effective or prophylactic ally effective amount of minoxidil, or a similar antihypertensive vasodilator, and a pharmaceutical composition for oral administration comprising a therapeutically effective or prophylactically effective amount of a 5-alpha reductase inhibitor. [0009] In yet another aspect, this disclosure provides a method of treating or preventing androgenic alopecia in a subject in need thereof comprising administering by oral administration a disclosed pharmaceutical package to said subject. [0010] Numerous other aspects are provided in accordance with these and other aspects of the invention. Other features and aspects of the present invention will become more fully apparent from the following detailed description and the appended claims. DETAILED DESCRIPTION [0011] As used herein, unless otherwise indicated, the word “a” or “plurality” before a noun represents one or more of the particular noun. [0012] Unless otherwise stated herein, the term “a single pharmaceutical composition” does not represent more than one composition. [0013] For the terms “for example” and “such as,” and grammatical equivalences thereof, the phrase “and without limitation” is understood to follow unless explicitly stated otherwise. As used herein, the term “about” is meant to account for variations due to experimental error. All measurements reported herein are understood to be modified by the term “about,” whether or not the term is explicitly used, unless explicitly stated otherwise. As used herein, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. [0014] “Effective amount,” “prophylactically effective amount,” or “therapeutically effective amount” refers to an amount of an agent or composition that provides a beneficial effect or favorable result to a subject, or alternatively, an amount of an agent or composition that exhibits the desired in vivo or in vitro activity. “Effective amount,” “prophylactically effective amount,” or “therapeutically effective amount” refers to an amount of an agent or composition that provides the desired biological, therapeutic, and/or prophylactic result. That result can be reduction, amelioration, palliation, lessening, delaying, and/or alleviation of on