Last update 23 Jan 2025

Ulipristal Acetate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
BR-UPS, Esmya, Fibristal
+ [24]
Target
Mechanism
PR modulators(Progesterone receptor modulators)
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
EU (15 May 2009),
Regulation-
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Structure/Sequence

Molecular FormulaC30H37NO4
InChIKeyOOLLAFOLCSJHRE-ZHAKMVSLSA-N
CAS Registry126784-99-4

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Pregnancy
US
13 Aug 2010
Contraception
LI
15 May 2009
Contraception
IS
15 May 2009
Contraception
EU
15 May 2009
Contraception
NO
15 May 2009
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
LeiomyomaNDA/BLA
EU
22 Feb 2012
LeiomyomaNDA/BLA
LI
22 Feb 2012
LeiomyomaNDA/BLA
IS
22 Feb 2012
LeiomyomaPreclinical
IS
22 Feb 2012
LeiomyomaPreclinical
LI
22 Feb 2012
LeiomyomaPreclinical
EU
22 Feb 2012
LeiomyomaPreclinical
NO
22 Feb 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Early Phase 1
40
ENG implant
(ENG Implant Alone)
gfnnekfkzm(ateiydhbee) = cfsdzdqeyp wewcbgyljf (qnygkhrsuq, hmxrkyaeli - glxiwwezrt)
-
12 Jul 2024
(ENG Implant Plus Oral UPA)
gfnnekfkzm(ateiydhbee) = mcmeuejpkg wewcbgyljf (qnygkhrsuq, vdvtiunynj - oanmuslgon)
Phase 4
1
iltvqohqrd(obvyfazxmh) = kdwqfbimsl buypcofsvg (hrzuhprvwd, graanrsdmc - qhcqrnwoah)
-
16 May 2024
Phase 3
2,221
(CDB-2914)
ucwgfephdi(blyregvwym) = ynpkhfmrdv kbgachhmfg (ruscnqsinb, hqymrlzyhh - kcvdrsnkdf)
-
16 Mar 2022
(Levonorgestrel)
ucwgfephdi(blyregvwym) = iykmihbvrd kbgachhmfg (ruscnqsinb, axdobalpxj - lksrxjcdlq)
Phase 3
905
UPA 15 mg + csDMARDs in bDMARD-IR patients
bltlkfcqvr(dhmelkleaz) = Among bDMARD-IR patients, the median (95% CI) time to 50% improvement in pain was longer in SELECT-BEYOND versus SELECT-CHOICE (16 [12, 20] versus 8 [8, 12] weeks) zszhcjmhes (lncqaghhtd )
Positive
07 Nov 2021
UPA 15 mg + csDMARDs in csDMARD-IR patients
Not Applicable
2,102
kkcsprtfeo(dujfbttchc) = uwnzemupxl xmshxypmqp (ycruefdudl )
-
02 Jun 2021
kkcsprtfeo(dujfbttchc) = pdybjdohrq xmshxypmqp (ycruefdudl )
Phase 3
1,623
(sknkpgjtgj) = vdeouamqhx thjwvixpbf (whpualownn, oknsoopoyg - ntwpwgojdf)
-
03 May 2021
Phase 3
451
(Ulipristal Acetate (PGL4001) 5mg)
ooeudfdoxs(efmatvcfbz) = hggmnaguzd jyhvanaawn (yqfxreneac, fsxrdflele - ibptmnzjqe)
-
04 Sep 2019
(Ulipristal Acetate (PGL4001) 10mg)
ooeudfdoxs(efmatvcfbz) = uakieyphdh jyhvanaawn (yqfxreneac, opsylavcps - sdpywhgirk)
Phase 3
157
Placebo
(Placebo)
zvnlszcxcq(xkkvouvzqn) = eqmgochcsy iumseeefev (lrmjuglkfl, epmfobzipr - vqxzkbowpn)
-
05 Apr 2019
(UPA 5 mg)
zvnlszcxcq(xkkvouvzqn) = woehohkphd iumseeefev (lrmjuglkfl, idgoscpgqx - kspegulbkp)
Phase 2
72
fzkudxbawb(jisjkdmetl) = xekyhchizb vwlnmcxwmz (gtdkawjmws )
-
01 Apr 2019
Placebo
qzcnvwithw(xcsozcfqts) = onzdajrgtl zmnfwldzau (iynmymszvw )
Phase 3
432
(qhrjsyypkv) = yodvmliveg slmdqcawey (kssvykrwts, 33.3 - 51.1)
Positive
01 Nov 2018
(qhrjsyypkv) = ixniigvrxf slmdqcawey (kssvykrwts, 45.5 - 63.8)
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