US0094.80728B2 (12) United States Patent (10) Patent No.: US 9.480,728 B2 Endo (45) Date of Patent: Nov. 1, 2016 (54) AGENT FOR THE TREATMENT OF FOREIGN PATENT DOCUMENTS ALOPECIA EP O497368 A1 8, 1992 EP 1810716 7/2007 (71) Applicants:IGISU Co., Ltd., Tokyo (JP); Yori EP 2308.889 4, 2011 Endo, Sendai-shi, Miyagi (JP) JP HE-052O7891 8, 1993 JP HE-06009688 1, 1994 JP 2000-169387 6, 2000 (72) Inventor: Kyoko Endo, Sendai (JP) JP 2000-516836 12/2000 JP 2007-70336 3, 2007 (73) Assignees: IGISU Co., Ltd., Tokyo (JP); Yori JP 2007-525213 9, 2007 Endo, Sendai-shi, Miyagi (JP); Kyoko JP 2007-525957 9, 2007 Endo, Sendai-shi, Miyagi (JP) JP 2008-5O9746 4/2008 JP 2008-162987 T 2008 JP 2008-540509 11/2008 (*) Notice: Subject to any disclaimer, the term of this JP 2009-13122 1, 2009 patent is extended or adjusted under 35 JP 2010-500032 1, 2010 U.S.C. 154(b) by 0 days. JP 2010-168283 8, 2010 JP 2010-280696 12/2010 JP 2010-539022 12/2010 (21) Appl. No.: 14/254,938 WO WO 98-52599 11, 1998 WO WO 2004-022003 3, 2004 (22) Filed: Apr. 17, 2014 WO WO 2004-071469 8, 2004 (65) Prior Publication Data (Continued) US 2014/031581.0 A1 Oct. 23, 2014 OTHER PUBLICATIONS Sawaya et al., Why steroids may not always work in alopecia areata: Related U.S. Application Data elevated unoccupied glucocorticoid receptors and decreased levels of thioredoxin. Dermatol. Ther. 14, 317-321, 2001.* (63) Continuation of application No. 13/355,484, filed on NCBI search, Feb. 25, 2015.* Jan. 21, 2012, now abandoned. Agoston H et al., Dexamethasone stimulates expression of C-type (60) Provisional application No. 61/437,032, filed on Jan. Natriuretic Peptide in chondrocytes, BMC Musculoskeletal Disor 28, 2011. ders, Nov. 20, 2006, p. 1-7, vol. 7, No. 87. Arase S, Japanese Dermatological Association alopecia areata diag (30) Foreign Application Priority Data nosis and treatment guidelines 2010. The Japanese Journal of Dermatology, Apr. 21, 2011, p. 1841-1859, vol. 120, No. 9. Jan. 21, 2011 (JP) ................................... 2011-11437 (Continued) (51) Int. Cl. A6 IK 38/22 (2006.01) Primary Examiner — Elly-Gerald Stoica A6 IK 45/06 (2006.01) (74) Attorney, Agent, or Firm — Wolf, Greenfield & A6 IK 3/4 (2006.01) Sacks, P.C. A6 IK3I/506 (2006.01) A 6LX 3/573 (2006.01) (57) ABSTRACT A6 IK3I/7036 (2006.01) It is an object of the present invention to provide a new agent (52) U.S. Cl. for the treatment of allopecia, the agent being not only CPC ............... A61K 38/22 (2013.01); A61K 31/14 effective and safe for, in particular, alopecia areata, andro (2013.01); A61 K3I/506 (2013.01); A61 K genetic alopecia in a male, androgenetic alopecia in a 31/573 (2013.01); A61 K3I/7036 (2013.01); female, female pattern alopecia, postpartum alopecia, Seb A61K 45/06 (2013.01) orrheic alopecia, alopecia pityroides, senile alopecia, cancer (58) Field of Classification Search chemotherapy drug-induced alopecia, and alopecia due to None radiation exposure, but also effective for a target having See application file for complete search history. resistance to treatment with minoxidil or finasteride, there being no side effects such as an itching sensation, irritation, (56) References Cited or feminization, and no contraindications, the agent Sup pressing dandruff or having a therapeutic effect for white U.S. PATENT DOCUMENTS hair, and the therapeutic effect for alopecia being maintained 5,114,923 A 5, 1992 Seilharmer et al. for a long period even when use of the agent is stopped. 5,583,108 A 12/1996 Wei et al. The solution means of the present invention is an agent for 6,028,055 A 2/2000 Lowe et al. the treatment of alopecia containing as an active ingredient 6,818,619 B2 11/2004 Burnett, Jr. et al. a C-type natriuretic peptide (CNP), a B-type natriuretic 7.276,481 B2 10/2007 Golembo et al. 2006.0034.903 A1 2/2006 Maa et al. peptide (BNP), a derivative of these NPs, a chimeric peptide 2008.0070858 A1 3/2008 Mahapatra of these NPs, or a derivative of a chimeric peptide of these 2009, O104295 A1 4/2009 Kohno NPS. 2011 OO14180 A1 1/2011 Koide et al. 2012fO238498 A1 9, 2012 Endo 14 Claims, 63 Drawing Sheets US 9,480,728 B2 Page 2 (56) References Cited Olsen E et al., Alopecia areata investigational assessment guide lines, Journal of American Academy of Dermatology, Feb. 1999, p. 242-246, vol. 40, No. 2, Part 1. FOREIGN PATENT DOCUMENTS Olsen E. Current and novel methods for assessing efficacy of hair growth promotors in pattern hair loss, J Am Acad Dermatol., Feb. 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