446:
31:
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638:
Palovarotene is a retinoic acid receptor gamma (RARγ) agonist licensed to
Clementia Pharmaceuticals from Roche Pharmaceuticals. At Roche, palovarotene was evaluated in more than 800 individuals including healthy volunteers and patients with chronic obstructive pulmonary disease (COPD). A one-year
642:
In 2011, animal studies demonstrated that RARγ agonists, including palovarotene, blocked new bone formation in both an injury-induced mouse model of heterotopic ossification (HO) and a genetically modified biological mouse model of fibrodysplasia ossificans progressiva containing a continuously
960:
1400:
1577:
643:
active ACVR1/ALK2 receptor in a dose-dependent manner. A 2016 study demonstrated that palovarotene also inhibited spontaneous heterotopic ossification, maintained limb mobility and functioning, and restored skeletal growth in fibrodysplasia ossificans progressiva mouse models.
1242:
1374:
684:(EMA) recommended the refusal of the marketing authorization for palovarotene for the treatment of fibrodysplasia ossificans progressiva. In May 2023, the European Medicines Agency confirmed its recommendation to refuse marketing authorization for Sohonos.
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clinical trial. In
December 2022, the FDA declined to approve palovarotene for the fibrodysplasia ossificans progressive without additional clinical trial data. In January 2023, the
1977:
828:
173:
1187:"Palovarotene Inhibits Heterotopic Ossification and Maintains Limb Mobility and Growth in Mice With the Human ACVR1(R206H) Fibrodysplasia Ossificans Progressiva (FOP) Mutation"
1345:
1276:
1487:
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561:
InChI=1S/C27H30N2O2/c1-26(2)12-13-27(3,4)24-17-22(18-29-15-5-14-28-29)21(16-23(24)26)11-8-19-6-9-20(10-7-19)25(30)31/h5-11,14-17H,12-13,18H2,1-4H3,(H,30,31)/b11-8+
697:
Clementia submitted a new drug application for palovarotene for the treatment of fibrodysplasia ossificans progressiva after observing positive phase II results.
61:
1599:
533:
1309:
1970:
1397:"Clementia Pharmaceuticals Receives EMA Orphan Medicinal Product Designation for Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva"
899:
860:
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1629:
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clinical studies failed to show a significant change in heterotopic bone volume, the main outcome measure, but prompted further investigation in a
709:
issued a partial clinical hold for people under the age of 14, due to reports of early fusion of growth plates. Ipsen acquired
Clementia in 2019.
639:
trial did not demonstrate a significant benefit on lung density in moderate-to-severe emphysema secondary to severe α(1)-antitrypsin deficiency.
1563:
Text was copied from this source which is copyright
European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
1963:
1921:
592:
1746:
957:"Health Canada Approves Ipsen's Sohonos (palovarotene capsules) as the First Approved Treatment for Fibrodysplasia Ossificans Progressiva"
1371:"Clementia Pharmaceuticals Receives Fast Track Designation for Palovarotene for Treatment of Fibrodysplasia Ossificans Progressiva (FOP)"
1892:
1574:"Clementia Announces Plan to Submit a New Drug Application for Palovarotene for the Treatment of FOP Based on Positive Phase 2 Results"
1550:
1424:"Palovarotene for Fibrodysplasia Ossificans Progressiva (FOP): Results of a Randomized, Placebo-Controlled, Double-Blind Phase 2 Trial"
820:
1019:
Hind M, Stinchcombe S (November 2009). "Palovarotene, a novel retinoic acid receptor gamma agonist for the treatment of emphysema".
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1331:
930:
263:
203:
93:
737:
1264:
1479:
1853:
1332:"Public summary of opinion on orphan designation. Palovarotene for the treatment of fibrodysplasia ossificans progressiva"
1659:
for "An
Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva. (MOVE)" at
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668:(FDA) for the treatment of fibrodysplasia ossificans progressiva and orphan medicinal product designation by the
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149:
889:
850:
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1997:
1509:
1048:"Randomised controlled trial for emphysema with a selective agonist of the γ-type retinoic acid receptor"
760:"FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)"
2461:
1185:
Chakkalakal SA, Uchibe K, Convente MR, Zhang D, Economides AN, Kaplan FS, et al. (September 2016).
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It was approved for medical use in Canada in June 2022, and in the United States in August 2023. The US
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441:
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Stolk J, Stockley RA, Stoel BC, Cooper BG, Piitulainen E, Seersholm N, et al. (August 2012).
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1089:"Potent inhibition of heterotopic ossification by nuclear retinoic acid receptor-γ agonists"
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Pignolo RJ, Baujat G, Hsiao EC, Keen R, Wilson A, Packman J, et al. (October 2022).
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for the treatment of heterotopic ossification and fibrodysplasia ossificans progressiva.
1600:"Ipsen Initiates Partial Clinical Hold for Palovarotene IND120181 and IND135403 Studies"
1087:
Shimono K, Tung WE, Macolino C, Chi AH, Didizian JH, Mundy C, et al. (April 2011).
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789:"Notice: Multiple Additions to the Prescription Drug List (PDL) [2022-01-24]"
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6-(N-ethyl-N-(5-isobutoxy-4-isopropyl-2-(E)-styrylphenyl)amino)nicotinic acid
22:
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1235:"Ipsen announces FDA Priority Review for NDA in patients with FOP"
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CC1(CCC(C2=C1C=C(C(=C2)/C=C/C3=CC=C(C=C3)C(=O)O)CN4C=CC=N4)(C)C)C
385:
1959:
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1399:(Press release). Clementia Pharmaceuticals. 21 November 2014.
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1373:(Press release). Clementia Pharmaceuticals. 1 December 2014.
430:
212:
134:
1626:"Ipsen Completes Acquisition of Clementia Pharmaceuticals"
225:
1480:"FDA Tells Ipsen It Won't Approve Palovarotene for FOP"
2409:
1265:"Palovarotene Orphan Drug Designations and Approvals"
1138:"Derailing heterotopic ossification and RARing to go"
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959:(Press release). Ipsen. 24 January 2022.
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1021:Current Opinion in Investigational Drugs
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734:Therapeutic Goods Administration (TGA)
20:
1632:from the original on 15 December 2019
1606:from the original on 15 December 2019
1580:from the original on 15 December 2019
821:"Summary Basis of Decision - Sohonos"
593:fibrodysplasia ossificans progressiva
413:
70:
7:
2199:Retinoic acid metabolism inhibitors:
1523:from the original on 27 January 2023
1490:from the original on 29 January 2023
1428:Journal of Bone and Mineral Research
1312:from the original on 27 January 2023
1279:from the original on 29 January 2023
1245:from the original on 29 January 2023
1191:Journal of Bone and Mineral Research
1000:from the original on 10 January 2024
863:from the original on 29 January 2023
185:
168:Retinoic acid receptor gamma agonist
1553:from the original on 25 August 2023
902:from the original on 18 August 2023
740:from the original on 2 January 2024
393:
304:
1576:(Press release). 23 October 2018.
1403:from the original on 23 April 2016
1377:from the original on 23 April 2016
1351:from the original on 22 April 2016
1136:Kaplan FS, Shore EM (April 2011).
831:from the original on 6 August 2022
664:designations by the United States
14:
1695:Other drugs for disorders of the
1241:(Press release). 24 August 2022.
2419:
1052:The European Respiratory Journal
963:from the original on 29 May 2022
801:from the original on 29 May 2022
479:
473:
29:
983:New Drug Therapy Approvals 2023
931:"Sohonos- palovarotene capsule"
566:Key:YTFHCXIPDIHOIA-DHZHZOJOSA-N
2003:Tooltip Retinoic acid receptor
1854:Histone deacetylase inhibitors
1510:"Sohonos: Pending EC decision"
485:
467:
1:
2398:Receptor/signaling modulators
2237:-Retinoic acid (alitretinoin)
2023:-Retinoic acid (alitretinoin)
890:"Sohonos Product Information"
851:"Sohonos product information"
1773:Delandistrogene moxeparvovec
1271:Food and Drug Administration
992:Food and Drug Administration
666:Food and Drug Administration
612:Food and Drug Administration
597:retinoic acid receptor gamma
579:, sold under the brand name
2217:Tooltip Retinoid X receptor
614:(FDA) considers it to be a
595:. It is a highly selective
2478:
2346:LE135 (RAR beta selective)
2246:-Retinoic acid (tretinoin)
2052:-Retinoic acid (tretinoin)
1788:Antisense oligonucleotides
971:– via Business Wire.
587:used for the treatment of
457:Chemical and physical data
2389:
1916:
1547:European Medicines Agency
1515:European Medicines Agency
1340:European Medicines Agency
1304:European Medicines Agency
1065:10.1183/09031936.00161911
682:European Medicines Agency
670:European Medicines Agency
616:first-in-class medication
549:
529:
259:
28:
1778:Onasemnogene abeparvovec
1749:clostridium histolyticum
1411:– via PR Newswire.
1385:– via PR Newswire.
996:(Report). January 2024.
589:heterotopic ossification
1697:musculo-skeletal system
1653:Clinical trial number
271:4-ethenyl]benzoic acid
1308:. 17 September 2018.
2261:Docosahexaenoic acid
1486:. 27 December 2022.
736:. 11 December 2023.
1519:. 26 January 2023.
898:. 22 October 2009.
827:. 23 October 2014.
797:. 24 January 2022.
647:Society and culture
221:(Prescription only)
139: X (High risk)
25:
1943:Never to phase III
1661:ClinicalTrials.gov
1275:. 1 January 2013.
1154:10.1038/nm0411-420
705:In December 2019,
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2406:
1987:Retinoid receptor
1953:
1952:
1440:10.1002/jbmr.4655
1434:(10): 1891–1902.
1203:10.1002/jbmr.2820
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520:Interactive image
426:CompTox Dashboard
240:
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16:Chemical compound
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2266:Fluorobexarotene
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2147:Tazarotenic acid
2004:
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1878:Aceneuramic acid
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1549:. 27 July 2023.
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1093:Nature Medicine
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1543:"Sohonos EPAR"
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159:
154:
152:administration
146:
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130:
128:
120:
119:
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116:
98:
96:
90:
89:
82:
76:
75:
68:
58:
57:
54:
50:
49:
46:
40:
39:
35:
34:
15:
13:
10:
9:
6:
4:
3:
2:
2474:
2463:
2460:
2458:
2455:
2453:
2452:Benzoic acids
2450:
2448:
2445:
2443:
2440:
2439:
2437:
2427:
2417:
2413:
2400:
2399:
2395:
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2379:
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2364:
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2327:
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2322:
2319:
2317:
2314:
2311:
2310:
2307:
2304:
2301:
2297:
2294:
2292:
2291:Retinoic acid
2289:
2287:
2284:
2282:
2279:
2277:
2274:
2272:
2269:
2267:
2264:
2262:
2259:
2257:
2254:
2252:
2249:
2247:
2245:
2240:
2238:
2236:
2231:
2229:
2226:
2223:
2222:
2220:
2215:
2209:
2203:
2200:
2197:
2196:
2193:
2190:
2188:
2185:
2183:
2180:
2178:
2175:
2173:
2170:
2168:
2165:
2162:
2161:
2158:
2155:
2153:
2150:
2148:
2145:
2143:
2140:
2138:
2135:
2132:
2128:
2125:
2123:
2122:Retinoic acid
2120:
2118:
2115:
2113:
2110:
2108:
2105:
2103:
2100:
2098:
2095:
2093:
2090:
2088:
2085:
2083:
2080:
2078:
2075:
2073:
2070:
2068:
2065:
2063:
2060:
2058:
2055:
2053:
2051:
2046:
2044:
2041:
2039:
2036:
2034:
2031:
2029:
2026:
2024:
2022:
2017:
2015:
2012:
2009:
2008:
2006:
2001:
1995:
1991:
1988:
1981:
1976:
1974:
1969:
1967:
1962:
1961:
1958:
1942:
1940:
1937:
1936:
1934:
1931:
1928:
1925:
1923:
1920:
1919:
1915:
1909:
1906:
1904:
1901:
1899:
1896:
1894:
1891:
1889:
1886:
1884:
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1879:
1876:
1875:
1873:
1869:
1863:
1860:
1859:
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1855:
1851:
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1836:
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1828:
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1776:
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1707:
1702:
1698:
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1648:
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1579:
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1569:
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1552:
1548:
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1522:
1518:
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1511:
1505:
1502:
1489:
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1475:
1472:
1467:
1463:
1459:
1455:
1450:
1445:
1441:
1437:
1433:
1429:
1425:
1418:
1415:
1402:
1398:
1392:
1389:
1376:
1372:
1366:
1363:
1347:
1343:
1341:
1333:
1327:
1324:
1311:
1307:
1305:
1300:
1294:
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1278:
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1227:
1222:
1218:
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1196:
1192:
1188:
1181:
1178:
1173:
1169:
1164:
1159:
1155:
1151:
1147:
1143:
1139:
1132:
1129:
1124:
1120:
1115:
1110:
1106:
1102:
1099:(4): 454–60.
1098:
1094:
1090:
1083:
1080:
1075:
1071:
1066:
1061:
1058:(2): 306–12.
1057:
1053:
1049:
1042:
1039:
1034:
1030:
1026:
1022:
1015:
1012:
999:
995:
993:
984:
978:
975:
962:
958:
952:
949:
936:
932:
926:
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922:
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918:
914:
901:
897:
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895:Health Canada
891:
885:
883:
881:
879:
875:
862:
858:
857:
856:Health Canada
852:
846:
843:
830:
826:
825:Health Canada
822:
816:
813:
800:
796:
795:
794:Health Canada
790:
784:
781:
769:
765:
761:
755:
752:
739:
735:
731:
725:
723:
719:
712:
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687:
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679:
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631:
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582:
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356:
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336:
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323:
316:
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311:
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291:
287:
286:
284:
282:
278:
269:
265:
258:
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246:
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232:
223:
220:
210:
209:
207:
205:
201:
196:
188:
183:
180:
179:
177:
175:
171:
167:
165:
161:
158:
155:
153:
147:
141:
132:
131:
129:
127:
121:
114:
109:
100:
99:
97:
95:
91:
87:
83:
81:
77:
73:
69:
67:
63:
59:
56:R-667, RG-667
55:
51:
47:
45:
41:
38:Clinical data
36:
32:
27:
19:
2462:Orphan drugs
2396:
2313:Antagonists:
2312:
2271:Isotretinoin
2243:
2234:
2224:
2198:
2164:Antagonists:
2163:
2137:Tamibarotene
2117:Palovarotene
2116:
2112:Isotretinoin
2049:
2020:
2010:
1903:Palovarotene
1902:
1893:Chondrocytes
1748:
1747:Collagenase
1719:Hydroquinine
1654:
1652:
1634:. Retrieved
1620:
1608:. Retrieved
1594:
1582:. Retrieved
1568:
1555:. Retrieved
1546:
1537:
1525:. Retrieved
1513:
1504:
1492:. Retrieved
1484:Global Genes
1483:
1474:
1431:
1427:
1417:
1405:. Retrieved
1391:
1379:. Retrieved
1365:
1353:. Retrieved
1338:
1326:
1314:. Retrieved
1302:
1293:
1281:. Retrieved
1268:
1259:
1247:. Retrieved
1238:
1229:
1194:
1190:
1180:
1148:(4): 420–1.
1145:
1141:
1131:
1096:
1092:
1082:
1055:
1051:
1041:
1024:
1020:
1014:
1002:. Retrieved
989:
977:
965:. Retrieved
951:
939:. Retrieved
934:
904:. Retrieved
893:
865:. Retrieved
854:
845:
833:. Retrieved
824:
815:
803:. Retrieved
792:
783:
771:. Retrieved
763:
754:
742:. Retrieved
733:
704:
696:
655:
652:Legal status
641:
637:
625:
622:Medical uses
609:
580:
577:Palovarotene
576:
575:
415:CHEBI:188559
204:Legal status
198:Legal status
113:Palovarotene
94:License data
23:Palovarotene
18:
2152:Trifarotene
2107:Fenretinide
1929:from market
1839:Deflazacort
1821:Viltolarsen
1801:Drisapersen
1742:Chymopapain
1656:NCT03312634
1636:15 December
1610:15 December
1584:15 December
662:orphan drug
503: g·mol
290:410528-02-8
255:Identifiers
80:MedlinePlus
53:Other names
44:Trade names
2436:Categories
2251:Bexarotene
2167:BMS-195614
2142:Tazarotene
2102:Etretinate
1990:modulators
1862:Givinostat
1844:Vamorolone
1816:Nusinersen
1811:Golodirsen
1806:Eteplirsen
1796:Casimersen
1737:Bromelains
1527:28 January
1494:28 January
1316:28 January
1283:28 January
1249:28 January
867:28 January
773:22 October
713:References
585:medication
508:3D model (
496:Molar mass
375:28K6I5M16G
346:ChemSpider
281:CAS Number
264:IUPAC name
164:Drug class
2457:Tetralins
2447:Pyrazoles
2442:Retinoids
2326:LG-100754
2300:vitamin A
2286:LG-100754
2281:LG-101506
2276:LG-100268
2225:Agonists:
2202:Liarozole
2131:vitamin A
2043:Adapalene
2038:Acitretin
2028:AC-261066
2011:Agonists:
1939:Phase III
1927:Withdrawn
1908:Risdiplam
1888:Branaplam
1557:25 August
1466:250697248
1004:9 January
941:6 October
906:17 August
701:Phase III
678:phase III
628:indicated
150:Routes of
124:Pregnancy
72:Monograph
66:Drugs.com
2426:Medicine
2393:See also
2336:UVI-3003
2306:SR-11237
2192:MM-11253
2182:ER-50891
2033:AC-55649
1883:Ataluren
1630:Archived
1604:Archived
1578:Archived
1551:Archived
1521:Archived
1488:Archived
1458:35854638
1407:11 April
1401:Archived
1381:11 April
1375:Archived
1355:11 April
1346:Archived
1310:Archived
1277:Archived
1243:Archived
1221:26896819
1172:21475232
1123:21460849
1074:22282548
1033:19876792
998:Archived
961:Archived
935:DailyMed
900:Archived
861:Archived
835:6 August
829:Archived
799:Archived
738:Archived
693:Phase II
688:Research
674:Phase II
605:by mouth
326:DrugBank
315:10295295
174:ATC code
157:By mouth
126:category
108:DailyMed
2296:Retinol
2256:CD 3254
2177:CD-2665
2172:BMS-493
2127:Retinol
2082:CD-2314
2077:CD-1530
2072:BMS-961
2067:BMS-753
2062:BMS-493
1755:Trypsin
1729:Enzymes
1710:Quinine
1449:9804935
1212:4992469
1163:4913781
1114:3073031
744:7 March
634:History
601:agonist
599:(RARγ)
583:, is a
581:Sohonos
501:414.549
463:Formula
355:8470763
335:DB05467
301:PubChem
247:Rx-only
244:WARNING
229::
190:)
184: (
182:M09AX11
110::
86:a623038
48:Sohonos
2412:Portal
2376:HX-711
2366:PA-452
2361:PA-451
2356:CD3254
2351:LE-540
2341:HX-603
2331:PA-452
2321:HX-630
2316:HX-531
2228:9CDHRA
2187:LE-135
2087:CD-437
2057:AM-580
2014:9CDHRA
1922:WHO-EM
1464:
1456:
1446:
1219:
1209:
1170:
1160:
1121:
1111:
1072:
1031:
967:28 May
805:28 May
534:SMILES
395:D09365
241:
231:℞-only
217:
106:
2371:Rhein
2244:trans
2157:TTNPB
2097:EC 23
2092:Ch-55
2050:trans
1871:Other
1517:(EMA)
1462:S2CID
1349:(PDF)
1342:(EMA)
1335:(PDF)
1306:(EMA)
1273:(FDA)
1269:U.S.
1239:Ipsen
994:(FDA)
990:U.S.
986:(PDF)
707:Ipsen
554:InChI
510:JSmol
406:ChEBI
2242:all-
2048:all-
1638:2019
1612:2019
1586:2019
1559:2023
1529:2023
1496:2023
1454:PMID
1409:2016
1383:2016
1357:2016
1318:2023
1285:2023
1251:2023
1217:PMID
1168:PMID
1119:PMID
1070:PMID
1029:PMID
1006:2024
969:2022
943:2023
908:2023
869:2023
837:2022
807:2022
775:2023
746:2024
660:and
591:and
386:KEGG
366:UNII
62:AHFS
2235:cis
2213:RXR
2021:cis
1999:RAR
1701:M09
1444:PMC
1436:doi
1207:PMC
1199:doi
1158:PMC
1150:doi
1109:PMC
1101:doi
1060:doi
768:FDA
431:EPA
305:CID
187:WHO
2438::
2233:9-
2019:9-
1935::
1628:.
1602:.
1545:.
1512:.
1482:.
1460:.
1452:.
1442:.
1432:37
1430:.
1426:.
1344:.
1337:.
1301:.
1267:.
1237:.
1215:.
1205:.
1195:31
1193:.
1189:.
1166:.
1156:.
1146:17
1144:.
1140:.
1117:.
1107:.
1097:17
1095:.
1091:.
1068:.
1056:40
1054:.
1050:.
1025:10
1023:.
988:.
933:.
916:^
892:.
877:^
853:.
823:.
791:.
766:.
762:.
732:.
721:^
618:.
607:.
477:30
471:27
237:US
226:CA
219:S4
213:AU
135:AU
103:US
2414::
2302:)
2298:(
2133:)
2129:(
1979:e
1972:t
1965:v
1703:)
1699:(
1688:e
1681:t
1674:v
1640:.
1614:.
1588:.
1561:.
1531:.
1498:.
1468:.
1438::
1359:.
1320:.
1287:.
1253:.
1223:.
1201::
1174:.
1152::
1125:.
1103::
1076:.
1062::
1035:.
1008:.
945:.
910:.
871:.
839:.
809:.
777:.
748:.
512:)
489:2
486:O
483:2
480:N
474:H
468:C
433:)
429:(
239::
215::
137::
64:/
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