JP2022153586A - 毛髪の成長を刺激するためのアルファ-ケトブチレート、アルファ-ケトグルタレート、および2-ヒドロキシブチレート - Google Patents
毛髪の成長を刺激するためのアルファ-ケトブチレート、アルファ-ケトグルタレート、および2-ヒドロキシブチレート Download PDFInfo
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Abstract
Description
[0002] 本発明は、国立衛生研究所によって承認された認可番号R01 AT006889に基づく政府支援を受けてなされた。米国政府は、本発明に一定の権利を有する。
[0004] 毛髪は、毛包として知られる表皮中の深い袋様の構造から始まり、真皮を貫通している。毛根は、下方の毛包へと伸び、その根元が凹みを有する毛球へと太くなっている。新しく分裂する細胞は、毛髪の根元で増殖して、細胞を押し上げる。細胞は、押し上げられると徐々に死滅し、毛幹へと硬化する。
[0006] 本明細書では、新しい毛髪の成長を刺激する組成物および方法が開示される。
[式中、
R1は、水素、ハロゲン、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R2およびR3は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
またはR2およびR3は、それらが結合する原子と一緒になって、オキソを形成し、
R4、R5、およびR6は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R7、R8、R9、およびR10は、それぞれ独立に、水素、置換もしくは非置換アルキル、置換もしくは非置換ヘテロアルキル、置換もしくは非置換シクロアルキル、置換もしくは非置換ヘテロシクロアルキル、置換もしくは非置換アリール、または置換もしくは非置換ヘテロアリールである]またはその塩、および
添加剤
を含む医薬組成物を投与することを含む方法を対象とする。
[式中、
R1は、水素、ハロゲン、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R2およびR3は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
またはR2およびR3は、それらが結合する原子と一緒になって、オキソを形成し、
R4、R5、およびR6は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R7、R8、R9、およびR10は、それぞれ独立に、水素、置換もしくは非置換アルキル、置換もしくは非置換ヘテロアルキル、置換もしくは非置換シクロアルキル、置換もしくは非置換ヘテロシクロアルキル、置換もしくは非置換アリール、または置換もしくは非置換ヘテロアリールである]またはその塩、および添加剤
を含む剤形を対象とする。
[式中、
R1は、水素、ハロゲン、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R2およびR3は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであるか、またはR2およびR3は、それらが結合する原子と一緒になって、オキソを形成し、
R4、R5、およびR6は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R7、R8、R9、およびR10は、それぞれ独立に、水素、置換もしくは非置換アルキル、置換もしくは非置換ヘテロアルキル、置換もしくは非置換シクロアルキル、置換もしくは非置換ヘテロシクロアルキル、置換もしくは非置換アリール、または置換もしくは非置換ヘテロアリールである]またはその塩、および
組織浸透増強剤
を含む局所用医薬組成物を対象とする。
[0025] 本明細書に言及されるあらゆる刊行物、特許文書、および特許出願文書は、あたかもそれぞれ個々の刊行物、特許文書、または特許出願文書が、参照によって具体的に個々に組み込まれることが示されているのと同程度まで、参照によって本明細書に組み込まれる。
[0027] 先の概要および以下の詳細な説明の両方は、単に例示的および説明的であり、特許請求される本発明をさらに説明することを企図される。添付の図は、本発明をさらに理解するために含まれ、本明細書に組み込まれ、本明細書の一部を構成し、本発明のいくつかの実施形態を例示し、説明と一緒になって、本発明の原理を説明するのに役立つ。
[0034] 本明細書で開示されるとおり、α-KB、α-KG、および2-HGは、抜け毛を低減または阻害し、毛髪の成長を刺激し、および/または老化中の対象の色素形成を改善した。
[0042] 毛髪の成長を低減または阻害する疾患または状態
[0043] 抜け毛は、遺伝因子、疾患、ストレス、医薬、傷害もしくは外傷、老化、または不十分な毛髪ケアによって引き起こされ得る。遺伝性抜け毛、またはアンドロゲン性脱毛症は、毛包を縮小させるテストステロンを含めたアンドロゲンと呼ばれるあるクラスのホルモンに対する感受性を誘発する。毛包が縮小すると、毛髪がより細くなり、最終的には全くなくなる。これは男性型禿頭症および女性型禿頭症としても公知である。抜け毛を引き起こす疾患または状態には、梅毒;がん;自己免疫障害、例えば円形脱毛症、狼瘡、毛孔性扁平苔癬、サルコイドーシス;甲状腺機能低下症;多嚢胞性卵巣症候群;貧血;または抜毛癖などの状態、すなわち人が頭皮の毛髪、まつ毛もしくは眉毛を引き抜く強迫行動が含まれる。脂漏性皮膚炎および白癬(ringwork)(頭部白癬)などの真菌性原因、ならびに毛包炎脱毛症(decalvans)などの細菌性原因も、抜け毛をもたらす。例えば妊娠中、または経口避妊薬もしくは閉経に起因するホルモンレベルの変化も、抜け毛をもたらす。
[0046] 瘢痕を引き起こす病斑をもたらすいかなるタイプの頭皮の反応または傷害も、抜け毛または毛包の死滅を引き起こすおそれがある。
[0048] 化学療法は、通常、がんを処置するための医薬または薬物の使用を指す。化学療法薬物は、急速に成長するがん細胞を死滅させるのに十分に強力であるが、完全に健康な細胞に害を引き起こし、身体中に副作用を引き起こすおそれもある。化学療法は、毛髪の成長を助ける細胞に害を及ぼすことによって、抜け毛を引き起こすおそれがある。
[0051] ストレスは、手術に関係する抜け毛の主要因子である。ストレスを受けている最中、身体は、心臓、肺、筋肉および他の生命器官に栄養素を送る。その結果として、毛髪は弱くなるおそれがあり、ある場合には毛包が新しい毛髪の生成を停止する。これは休止期脱毛症と呼ばれる。これは、最も一般的なタイプの抜け毛であり、典型的に大手術、慢性疾病、または著しい感染症などの大きい身体ストレスを受けた後、2~3ヵ月間見られる。
[0053] 甲状腺障害には、甲状腺機能の低下(甲状腺機能低下症)および甲状腺機能の亢進(甲状腺機能亢進症)の両方が含まれる。毛髪の成長は、甲状腺の適切な機能に応じて変わり、この甲状腺によって生成される甲状腺ホルモンの異常レベルは、抜け毛のような毛髪変化をもたらすおそれがある。
[0055] 脳下垂体障害は、脳下垂体が、いくつかのホルモンの1つまたは複数を過剰または過少に生成する、脳下垂体の障害である。脳下垂体の障害は、様々な症状を引き起こし、ある場合には重症合併症をもたらすおそれがある。脳下垂体の問題の症状は、影響を受ける特定のホルモン、および特定のホルモンが過剰な量または不十分な量で存在するかどうかに応じて変わる。例えば、甲状腺-刺激ホルモン(TSH)の過剰産生は、抜け毛、緊張感、激しい心拍、および体重減少を含めた過活動甲状腺の症状を引き起こすおそれがある。
[0057] 円形禿頭症としても公知の円形脱毛症は、身体が、それ自体の体細胞を認識しなくなり、その後、それ自体の組織を破壊することにより、毛髪が身体の一部またはあらゆる領域から、通常は頭皮から喪失される自己免疫疾患である。(1)線維症、炎症、および毛包の喪失が存在する瘢痕性脱毛症、ならびに(2)毛幹がなくなるが毛包が保存されており、これにより、このタイプの脱毛症が可逆的となる非瘢痕性脱毛症の2つのタイプが存在する。
[0059] 成長期脱毛症は、毛髪サイクルの成長期または成長段階中に生じる毛髪の抜落ちを指す。成長期脱毛症は、その有糸分裂または代謝活性を損なう毛包への任意の傷害後に生じる。成長期脱毛症は、びまん性非瘢痕性脱毛症(禿頭症)をもたらすおそれがある。
[0062] 本発明による化合物は、以下の構造式Iを有する化合物
[式中、
R1は、水素、ハロゲン、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、R2およびR3は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであるか、またはR2およびR3は、それらが結合する原子と一緒になって、オキソを形成し、R4、R5、およびR6は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、R7、R8、R9、およびR10は、それぞれ独立に、水素、置換もしくは非置換アルキル、置換もしくは非置換ヘテロアルキル、置換もしくは非置換シクロアルキル、置換もしくは非置換ヘテロシクロアルキル、置換もしくは非置換アリール、または置換もしくは非置換ヘテロアリールである]またはその塩
を含む。
[式中、
Raは、負電荷、H、-CH3、-CH2-CH3、直鎖もしくは分岐C1~C3アルキル、直鎖もしくは分岐C1~C4アルキル、直鎖もしくは分岐C1~C5アルキル、直鎖もしくは分岐C1~C10アルキル、-CH2=CH3、直鎖もしくは分岐C1~C3アルケニル、直鎖もしくは分岐C1~C4アルケニル、直鎖もしくは分岐C1~C5アルケニル、または直鎖もしくは分岐C1~C10アルケニルであり、
Rbは、H、-CH3、-CH2-CH3、直鎖もしくは分岐C1~C3アルキル、直鎖もしくは分岐C1~C4アルキル、直鎖もしくは分岐C1~C5アルキル、直鎖もしくは分岐C1~C10アルキル、-CH2=CH3、直鎖もしくは分岐C1~C3アルケニル、直鎖もしくは分岐C1~C4アルケニル、直鎖もしくは分岐C1~C5アルケニル、または直鎖もしくは分岐C1~C10アルケニルであり、
Rcは、任意選択により存在し、存在する場合、Rcは、H、-CH3、-CH2-CH3、直鎖もしくは分岐C1~C3アルキル、直鎖もしくは分岐C1~C4アルキル、直鎖もしくは分岐C1~C5アルキル、直鎖もしくは分岐C1~C10アルキル、-CH2=CH3、直鎖もしくは分岐C1~C3アルケニル、直鎖もしくは分岐C1~C4アルケニル、直鎖もしくは分岐C1~C5アルケニル、または直鎖もしくは分岐C1~C10アルケニルであり、存在しない場合、Zは、二重結合である]
ならびに薬学的に許容されるその溶媒和物、塩、プロドラッグおよび代謝産物が含まれる。
[式中、
RaおよびRbは、それぞれ独立に、負電荷、H、Na、直鎖もしくは分岐C1~C10アルキル、または直鎖もしくは分岐C1~C10アルケニルであり、
Rcは、任意選択により存在し、存在する場合、Rcは、H、直鎖もしくは分岐C1~C10アルキル、または直鎖もしくは分岐C1~C10アルケニルであり、存在しない場合、Zは、二重結合である]、
ならびに薬学的に許容されるその溶媒和物、塩、プロドラッグおよび代謝産物が含まれる。
[0076] 一部の実施形態では、本発明は、それを必要とする対象の新しい毛髪の成長を刺激する方法であって、対象に、治療有効量の式I、式II、および/または式IIIの1つまたは複数の化合物を投与することを含む方法を対象とする。一部の実施形態では、1つまたは複数の化合物は、本明細書に記載されるとおり、医薬組成物または製剤の形態で投与される。一部の実施形態では、1つまたは複数の化合物、組成物、または製剤は、新しい毛髪の成長が望ましい対象上の領域に投与される。
[式中、
R1は、水素、ハロゲン、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、R2およびR3は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであるか、またはR2およびR3は、それらが結合する原子と一緒になって、オキソを形成し、R4、R5、およびR6は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、R7、R8、R9、およびR10は、それぞれ独立に、水素、置換もしくは非置換アルキル、置換もしくは非置換ヘテロアルキル、置換もしくは非置換シクロアルキル、置換もしくは非置換ヘテロシクロアルキル、置換もしくは非置換アリール、または置換もしくは非置換ヘテロアリールである]またはその塩、および添加剤
を含む医薬組成物を投与することを含み、医薬組成物が、新しい毛髪の成長を刺激するために、毛髪がない対象上の領域に投与される方法を対象とする。
[式中、
R1は、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-SR10であり、R2およびR3は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-SR10、または置換もしくは非置換アルキルであるか、またはR2およびR3は、それらが結合する原子と一緒になって、オキソを形成し、R4、R5、およびR6は、それぞれ独立に、水素、ハロゲン、-OR7、-NR8R9、-COOR7、-CONR8R9、または置換もしくは非置換アルキルであり、R7、R8、R9、およびR10は、それぞれ独立に、水素、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルである]またはその塩、および添加剤を含む医薬組成物を投与することを含み、医薬組成物が、新しい毛髪の成長を刺激するために、毛髪がない対象上の領域に投与される方法を対象とする。
[式中、
R1は、-OR7または-NR8R9であり、R2およびR3は、それぞれ独立に、水素、-CHO、-OR7、-NR8R9、または非置換アルキルであるか、またはR2およびR3は、それらが結合する原子と一緒になって、オキソを形成し、R4、R5、およびR6は、それぞれ独立に、水素、-OR7、-NR8R9、または非置換アルキルであり、R7、R8、R9、およびR10は、それぞれ独立に、水素、または置換もしくは非置換アルキルである]またはその塩、および添加剤を含む医薬組成物を投与することを含み、医薬組成物が、新しい毛髪の成長を刺激するために、毛髪がない対象上の領域に投与される方法を対象とする。
[式中、
R1は、-OR7であり、R2およびR3は、それらが結合する原子と一緒になって、オキソを形成し、R4、R5、およびR6は、それぞれ独立に、水素または非置換アルキルであり、R7、R8、R9、およびR10は、それぞれ独立に、水素または非置換アルキルである]またはその塩、および添加剤を含む医薬組成物を投与することを含み、医薬組成物が、新しい毛髪の成長を刺激するために、毛髪がない対象上の領域に投与される方法を対象とする。
[0092] 式I、式II、および式IIIの化合物は、追加の薬剤と併用投与することができる。追加の薬剤は、1つまたは複数の成長因子を含むことができる。一部の実施形態では、成長因子は、TGF-β2、IGF-1、KGFまたはHGFを含む。
[0100] 対象に投与される式I、式II、および/または式IIIの1つまたは複数の化合物(例えば、式Iの2つの異なる化合物;式IIの化合物および式IIIの化合物、例えば1つもしくは複数のα-KB化合物および/または1つもしくは複数のグルタレート化合物など)は、医薬組成物または製剤として投与され得る。医薬組成物および製剤は、前述のとおり追加の薬剤をさらに含むことができる。
[0140] 本発明の医薬製剤は、経口、直腸、経鼻、局所(口腔内頬側および舌下を含む)、膣内、および非経口(皮下、筋肉内、静脈内、および皮内を含む)を含めた任意の適切な経路によって投与され得る。さらに、本発明による医薬組成物は、処置される患者が経口摂取するための、水性経口分散液剤、液剤、ゲル剤、シロップ剤、エリキシル剤、スラリー剤、懸濁液剤など、固体経口剤形、エアロゾル剤、制御放出製剤、急速溶融製剤、発泡性製剤、凍結乾燥製剤、錠剤、散剤、丸剤、糖衣錠、カプセル剤、遅延放出製剤、延長放出製剤、パルス放出製剤、多粒子製剤、ならびに即時放出製剤および制御放出製剤の混合物を含めた任意の適切な剤形に製剤化され得る。
[0142] 一部の実施形態では、本明細書に記載される化合物は、局所投与することができ、様々な局所投与可能な組成物、例えば溶液剤、懸濁液剤、ローション剤、ゲル剤、ペースト剤、薬用スティック剤、バーム剤、クリーム剤または軟膏剤に製剤化され得る。このような医薬化合物は、可溶化剤、安定剤、浸透圧増強剤、緩衝液および保存剤を含有することができる。
[0159] 経口使用のために製剤化された医薬組成物は、1つまたは複数の固体添加剤を、式I、式IIおよび/または式IIIの化合物の1つまたは複数と混合し、任意選択により得られた混合物を粉砕し、必要に応じて適切な助剤を添加した後に顆粒の混合物を処理して、錠剤または糖衣錠コアを得ることによって得られる。適切な添加剤の例として、充填剤、例えばラクトース、スクロース、マンニトールもしくはソルビトールを含めた糖;セルロース調製物、例えば、トウモロコシデンプン、コムギデンプン、コメデンプン、バレイショデンプン、ゼラチン、トラガカントガム、メチルセルロース、微結晶性セルロース、ヒドロキシプロピルメチルセルロース、カルボキシメチルセルロースナトリウムなど;またはポリビニルピロリドン(PVPまたはポビドン)もしくはリン酸カルシウムなどの他の添加剤が挙げられる。必要に応じて、架橋クロスカルメロースナトリウム、ポリビニルピロリドン、寒天、またはアルギン酸もしくはその塩、例えばアルギン酸ナトリウムなどの崩壊剤が添加される。
[0179] 一部の実施形態では、医薬製剤は、ドライシャンプーおよび噴霧剤を含むエアロゾル組成物であり、ここで組成物は、泡状物質またはムースとして適用するためには製剤化されない。「ドライシャンプー」とは、揮発性液体であり、したがって蒸発する担体材料、および残る粉末、例えば、デンプンまたは加工デンプン、例えばアルミニウムデンプンオクテニルスクシネートを含む製剤を意味する。一部の実施形態では、ドライシャンプーは、式I、式II、および/または式IIIの1つまたは複数の化合物、担体材料を含む。揮発性液体である適切な担体材料の例として、それらに限定されるものではないが、エタノールまたはイソプロパノールを含めた低級アルコール、揮発性シリコーン化合物、例えばポリジメチルシロキサン(例えば、25℃で約5cSt未満の粘度を有する)、シクロメチコン、シクロヘキサンシロキサン、デカメチルテトラシロキサン、オクタメチルトリシロキサン、デカメチルペンタシロキサン、デカメチルシクロペンタシロキサン、オクタメチルシクロテトラシロキサン、トリメチルシリルアモジメチコン、フェニルトリメチコン、ヘキサメチルジシロキサン(hexamethyidisiloxane)、およびジメチルシロキサン/メチルアルキルシロキサン、ならびにそれらの組合せが挙げられる。当業者に公知の他の担体材料を使用することもできる。エアロゾル組成物における担体材料の総百分率重量は、エアロゾルドライシャンプー組成物(ドライシャンプー組成物および噴霧剤の組合せ)の総重量の約0.1%~約50%の間、約0.1%~約40%の間、約1%~約35%の間、約5%~約50%の間、約10%~約40%の間、約15%~約40%の間であってよい。一部の実施形態では、組成物は、実質的に水を含まない。
[0193] 一部の実施形態では、本発明は、本明細書に記載される1つまたは複数の方法と併用するためのキットおよび製品を対象とする。このようなキットは、例えばバイアル、管などの1つまたは複数の容器を入れるように区分けされている担体、パッケージ、または容器を含み、容器(複数可)のそれぞれは、本明細書に記載される方法で使用される別々の要素の1つを含む。適切な容器には、例えば、ボトル、バイアル、シリンジ、および試験管が含まれる。一部の実施形態では、容器は、ガラスまたはプラスチックなどの様々な材料から形成される。
[0200] 以下の実施例は、本発明を制限することなく例示することを企図する。
[0202] α-KB、2-HB、およびα-KGが毛髪の成長を刺激する効果を調査するために、剃毛した若い(6週齢)C57/B6マウスを局所処置し、3週間にわたって色素形成ならびに毛髪変化についてモニタリングした。化合物を、16mMで経皮ゲル剤に溶解させ、マウス背部皮膚に1日おきに塗った。色素形成の進行を示すために、成長期開始の信号を示す皮膚色素形成の出現を、皮膚暗色化に基づいて任意の値に割り当てた。毛髪の成長なし(および色素形成なし)に、0の任意の値を割り当て、より濃い皮膚/目に見える毛髪の成長に、より高い数値を割り当てた。毎週写真を撮影して、色素形成/毛髪変化を記録した。
[0205] 線虫におけるα-KBの生涯期間延長効果に基づいて(図2)、マウスにおける抗老化特性を調査した。101週齢の高齢C57BL/6Jマウスを、飲料水に溶解させた8mMのα-KB酸で30週間まで処置した。α-KBの投与は、高齢マウスにおける老化特質(白内障など)を防止し、雄性動物の生存を、131週齢を超えるまで著しく延長した(*P=0.0476)(図3)。コントロール群では、老化中に、背部皮膚上の毛髪は著しく灰色になり、より細くなったが(禿頭)、α-KBで処置したマウスは、黒色の太い毛髪を示した(図4)。
[0208] 6週齢のマウスの毛髪の成長を刺激する、α-KBが有する役割を調査した。背部毛髪を、トリマーで7週目に剃毛し、α-KB酸を、経皮ゲル剤に16mMで溶解させ、マウスの背部皮膚上に1日おきに塗った。処置した皮膚は、1週間後に色素形成の斑点を示し始め(図5)、それらの毛髪の成長は、コントロールと比較してα-KB処置によって加速された(図6)。
[0211] ある場合には、α-KB、α-KG、および2-HBは、毛髪の成長を刺激し、対象の色素形成を改善することが実証された。
[0213] 実施形態1:対象の抜け毛を処置、阻害、または低減するための方法であって、対象に、治療有効量の1つもしくは複数のα-ケトブチレート化合物および/または1つもしくは複数のグルタレート化合物を投与することを含む、方法。
[式中、
R1は、水素、ハロゲン、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R2およびR3は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであるか、またはR2およびR3は、それらが結合する原子と一緒になって、オキソを形成し、
R4、R5、およびR6は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R7、R8、R9、およびR10は、それぞれ独立に、水素、置換もしくは非置換アルキル、置換もしくは非置換ヘテロアルキル、置換もしくは非置換シクロアルキル、置換もしくは非置換ヘテロシクロアルキル、置換もしくは非置換アリール、または置換もしくは非置換ヘテロアリールである]またはその塩、および
添加剤
を含む医薬組成物を投与することを含み、
医薬組成物が、新しい毛髪の成長を刺激するために、毛髪がない対象上の領域に投与される、方法。
[式中、
R1は、水素、ハロゲン、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R2およびR3は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであるか、またはR2およびR3は、それらが結合する原子と一緒になって、オキソを形成し、
R4、R5、およびR6は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R7、R8、R9、およびR10は、それぞれ独立に、水素、置換もしくは非置換アルキル、置換もしくは非置換ヘテロアルキル、置換もしくは非置換シクロアルキル、置換もしくは非置換ヘテロシクロアルキル、置換もしくは非置換アリール、または置換もしくは非置換ヘテロアリールである]またはその塩、
および添加剤
を含む、剤形。
[式中、
R1は、水素、ハロゲン、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R2およびR3は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであるか、またはR2およびR3は、それらが結合する原子と一緒になって、オキソを形成し、
R4、R5、およびR6は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R7、R8、R9、およびR10は、それぞれ独立に、水素、置換もしくは非置換アルキル、置換もしくは非置換ヘテロアルキル、置換もしくは非置換シクロアルキル、置換もしくは非置換ヘテロシクロアルキル、置換もしくは非置換アリール、または置換もしくは非置換ヘテロアリールである]またはその塩、および
組織浸透増強剤
を含む、局所用医薬組成物。
Claims (20)
- 対象の、抜け毛を処置、阻害もしくは低減するため、毛髪の成長を改善もしくは刺激するため、色素喪失を処置、阻害もしくは低減するため、および/または色素生成を改善もしくは刺激するための方法であって、前記対象に、治療有効量の1つもしくは複数のアルファ-ケトブチレート化合物および/または1つもしくは複数のグルタレート化合物を投与することを含む、方法。
- 1つまたは複数のアルファ-ケトブチレート化合物が、アルファ-ケトブチレート(α-KB)であり、1つまたは複数のグルタレート化合物が、アルファ-ケトグルタレート(α-KG)であり、および/または1つまたは複数のグルタレート化合物が、2-ヒドロキシペンタンジオエート(2-HG)である、請求項1に記載の方法。
- 治療有効量の式Iの化合物
[式中、
R1は、水素、ハロゲン、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R2およびR3は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであるか、またはR2およびR3は、それらが結合する原子と一緒になって、オキソを形成し、
R4、R5、およびR6は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R7、R8、R9、およびR10は、それぞれ独立に、水素、置換もしくは非置換アルキル、置換もしくは非置換ヘテロアルキル、置換もしくは非置換シクロアルキル、置換もしくは非置換ヘテロシクロアルキル、置換もしくは非置換アリール、または置換もしくは非置換ヘテロアリールである]またはその塩、および
添加剤
を含む組成物を対象に投与することを含む、それを必要とする対象の新しい毛髪の成長を刺激する方法であって、
前記組成物が、新しい毛髪の成長を刺激するために、毛髪がない対象上の領域に投与される、方法。 - 式Iの化合物
[式中、
R1は、水素、ハロゲン、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R2およびR3は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであるか、またはR2およびR3は、それらが結合する原子と一緒になって、オキソを形成し、
R4、R5、およびR6は、それぞれ独立に、水素、ハロゲン、-CN、-CHO、-OR7、-NR8R9、-COOR7、-CONR8R9、-NO2、-SR10、置換もしくは非置換アルキル、または置換もしくは非置換ヘテロアルキルであり、
R7、R8、R9、およびR10は、それぞれ独立に、水素、置換もしくは非置換アルキル、置換もしくは非置換ヘテロアルキル、置換もしくは非置換シクロアルキル、置換もしくは非置換ヘテロシクロアルキル、置換もしくは非置換アリール、または置換もしくは非置換ヘテロアリールである]またはその塩、
ならびに薬学的に許容される添加剤および/または組織浸透増強剤
を含む、組成物。 - R1が、
(a)水素、-CHO、または-OR7であるか、
(b)R7が水素、置換もしくは非置換アルキル、または置換もしくは非置換アリールである、-OR7であるか、または
(c)R7がC1~20置換または非置換アルキルである、-OR7である、請求項3に記載の方法または請求項4に記載の組成物。 - (a)R2が、水素、ハロゲン、-CN、-CHO、または-NR8R9であり、R8およびR9が、それぞれ独立に、水素、または置換もしくは非置換アルキルであるか、または
(b)R2およびR3が、それらが結合する原子と一緒になって、オキソを形成する、請求項3に記載の方法、請求項4に記載の組成物、または請求項5に記載の方法もしくは組成物。 - R4、R5、およびR6が、それぞれ独立に、水素、-CHO、-OR7、-NR8R9、-COOR7、または-CONR8R9であり、R7、R8、およびR9が、それぞれ独立に、水素、またはC1~20置換もしくは非置換アルキルである、請求項3に記載の方法、請求項4に記載の組成物、または請求項5もしくは請求項6に記載の方法もしくは組成物。
- R4が、-COOR7または-CONR8R9であり、R7、R8、およびR9が、それぞれ独立に、水素、またはC1~20置換もしくは非置換アルキルである、請求項3に記載の方法、請求項4に記載の組成物、または請求項5~7のいずれか一項に記載の方法もしくは組成物。
- 式Iの化合物が、アルファ-ケトグルタレート(α-KG)、2-HB、またはアルファ-ケトブチレート(α-KB)である、請求項3に記載の方法、請求項4に記載の組成物、または請求項5~8のいずれか一項に記載の方法もしくは組成物。
- 組成物中の式Iの化合物の濃度が、少なくとも1mM、2mM、3mM、4mM、5mM、6mM、7mM、8mM、9mM、10mM、11mM、12mM、13mM、14mM、15mM、16mM、17mM、18mM、19mM、20mM、25mM、30mM、35mM、40mM、45mM、または50mMである、請求項3に記載の方法、請求項4に記載の組成物、または請求項5~9のいずれか一項に記載の方法もしくは組成物。
- 組成物が、経口、非経口、または局所投与のために製剤化される、請求項3に記載の方法、請求項4に記載の組成物、または請求項5~10のいずれか一項に記載の方法もしくは組成物。
- 組成物が、ゲル剤、クリーム剤、軟膏剤、ペースト剤、またはローション剤として製剤化される、請求項3に記載の方法、請求項4に記載の組成物、または請求項5~10のいずれか一項に記載の方法もしくは組成物。
- 組成物が、TGF-β2、IGF-1、KGF、およびHGFなどの1つまたは複数の成長因子をさらに含む、請求項3に記載の方法、請求項4に記載の組成物、または請求項5~12のいずれか一項に記載の方法もしくは組成物。
- 組成物が、細胞と接触すると、成長期に入るように細胞を刺激することができる、請求項3に記載の方法、請求項4に記載の組成物、または請求項5~13のいずれか一項に記載の方法もしくは組成物。
- 領域が、毛髪の成長を低減もしくは阻害する疾患もしくは状態、傷害、化学療法および/もしくは放射線治療、または手術に起因して毛髪がない、請求項3および5~14のいずれか一項に記載の方法。
- 対象が、甲状腺障害、脳下垂体障害、円形脱毛症、成長期脱毛症、および/または休止期脱毛症を有している、請求項3および5~15のいずれか一項に記載の方法。
- 組成物を投与した後の対象の毛包の数が、組成物を投与する前の対象の毛包の数と比較して多い、請求項3および5~15のいずれか一項に記載の方法。
- 組成物を投与した後の対象の毛髪の重量が、組成物を投与する前の対象の毛髪の重量と比較して重い、請求項3および5~15のいずれか一項に記載の方法。
- 組成物を投与した後の対象の毛髪の毛幹の長さが、組成物を投与する前の対象の毛髪の毛幹の長さと比較して速く増大する、請求項3および5~15のいずれか一項に記載の方法。
- 組成物を投与した後の対象の毛髪の成長速度が、組成物を投与する前の対象の成長速度と比較して増大する、請求項3および5~15のいずれか一項に記載の方法。
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