Drug Type Small molecule drug |
Synonyms Upadacitinib Hydrate, Upadacitinib tartrate, A-1293543.0 + [6] |
Target |
Mechanism JAK1 inhibitors(Tyrosine-protein kinase JAK1 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (16 Aug 2019), |
RegulationOrphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Special Review Project (CN) |
Molecular FormulaC34H40F6N12O3 |
InChIKeyGJMQTRCDSIQEFK-SCDRJROZSA-N |
CAS Registry2050057-56-0 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10994D11048 | Upadacitinib hemihydrate |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Polyarticular Juvenile Idiopathic Arthritis | US | 26 Apr 2024 | |
Crohn's disease, active moderate | EU | 24 Apr 2023 | |
Crohn's disease, active moderate | IS | 24 Apr 2023 | |
Crohn's disease, active moderate | LI | 24 Apr 2023 | |
Crohn's disease, active moderate | NO | 24 Apr 2023 | |
Crohn's disease, active severe | EU | 24 Apr 2023 | |
Crohn's disease, active severe | IS | 24 Apr 2023 | |
Crohn's disease, active severe | LI | 24 Apr 2023 | |
Crohn's disease, active severe | NO | 24 Apr 2023 | |
Crohn Disease | CA | 16 Jan 2020 | |
Ankylosing Spondylitis | EU | 16 Dec 2019 | |
Ankylosing Spondylitis | IS | 16 Dec 2019 | |
Ankylosing Spondylitis | LI | 16 Dec 2019 | |
Ankylosing Spondylitis | NO | 16 Dec 2019 | |
Arthritis, Psoriatic | EU | 16 Dec 2019 | |
Arthritis, Psoriatic | IS | 16 Dec 2019 | |
Arthritis, Psoriatic | LI | 16 Dec 2019 | |
Arthritis, Psoriatic | NO | 16 Dec 2019 | |
Axial Spondyloarthritis | EU | 16 Dec 2019 | |
Axial Spondyloarthritis | IS | 16 Dec 2019 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Giant Cell Arteritis | NDA/BLA | US | 12 Jul 2024 | |
Giant Cell Arteritis | NDA/BLA | EU | 12 Jul 2024 | |
Dyssomnias | Phase 3 | - | 23 May 2024 | |
Nonsegmental vitiligo | Phase 3 | US | 19 Dec 2023 | |
Nonsegmental vitiligo | Phase 3 | CN | 19 Dec 2023 | |
Nonsegmental vitiligo | Phase 3 | JP | 19 Dec 2023 | |
Nonsegmental vitiligo | Phase 3 | AR | 19 Dec 2023 | |
Nonsegmental vitiligo | Phase 3 | BE | 19 Dec 2023 | |
Nonsegmental vitiligo | Phase 3 | BG | 19 Dec 2023 | |
Nonsegmental vitiligo | Phase 3 | CA | 19 Dec 2023 |
Phase 3 | tumor necrosis factor | interleukin-17 inhibitor | 420 | gpzzivtypz(rnotjqadji) = kvzkbuorhf xyusluzwkp (ooztcvegyk ) | Positive | 12 Nov 2024 | ||
Placebo to upadacitinib | gpzzivtypz(rnotjqadji) = gfmhmnyqpw xyusluzwkp (ooztcvegyk ) | ||||||
Phase 3 | Crohn's disease, active severe Maintenance | - | fvncxoumva(fhrftepura) = nvjujuvffl esznwifusb (cuftvoyqlc ) View more | Positive | 04 Nov 2024 | ||
Placebo | fvncxoumva(fhrftepura) = aunimqsvca esznwifusb (cuftvoyqlc ) View more | ||||||
Phase 3 | - | avnpshniny(bxspbjhyut) = dmujgkyswg cmzexkjdls (hoirqijzid ) | Positive | 01 Nov 2024 | |||
Placebo | avnpshniny(bxspbjhyut) = buoyrugccg cmzexkjdls (hoirqijzid ) | ||||||
Phase 3 | 542 | (AD Up) | lupmfvfbvz(tbohxpprgi) = noyxytksfu waloamjnrm (xxcqgykcxf ) | Positive | 23 Oct 2024 | ||
(Measure Up 1) | lupmfvfbvz(tbohxpprgi) = ldguqzlary waloamjnrm (xxcqgykcxf ) | ||||||
Not Applicable | - | - | jgtxugezmj(opekjqohqs) = AEs occurred at numerically higher rates for pts receiving UPA who failed ≥2 biologics in induction and maintenance studies. During induction, no malignancies or major adverse cardiovascular events (MACE) were reported, and there was 1 venous thromboembolic event (VTE) in the PBO group. During maintenance, across subgroups, rates of AEs of special interest were: malignancies (Non-Bio-IR: UPA15, 1.0 events/100 PY [E/100 PY]; UPA30, 1.8 E/100 PY; 1 prior biologic: PBO, 3.3 E/100 PY; UPA30, 5.5 E/100 PY; ≥2 prior biologics: UPA30, 1.8 E/100 PY), MACE (Non-Bio-IR: UPA30, 0.9 E/100 PY; 1 prior biologic: PBO, 3.3 E/100 PY) and VTE (Non-Bio-IR: UPA30, 1.8 E/100 PY), respectively. No AEs leading to death occurred in either study. fazssrdxpg (jvknecfmwt ) | - | 13 Oct 2024 | ||
Placebo | |||||||
Not Applicable | Colitis, Ulcerative fecal calprotectin | CRP | 139 | bsysosepux(csyuycmzjj) = In total, 104 adverse events (AE), of which most were non-serious (7.1%, (n = 15) SAEs), were documented. uplxoartkj (hfhbpgjhkf ) | Positive | 13 Oct 2024 | ||
Not Applicable | - | umdcywrfda(esuhmqkvsw) = pjtvhgtrym qafvygvszx (nmgnpovgvr, 0.5) View more | - | 13 Oct 2024 | |||
Placebo | umdcywrfda(esuhmqkvsw) = ljuxhxykha qafvygvszx (nmgnpovgvr, 0.7) View more | ||||||
Not Applicable | - | zqdmfyoyxi(cxjvmfunxs) = acne lljfndcogv (ksgxmthjqk ) View more | - | 13 Oct 2024 | |||
Not Applicable | - | sskbgdcdln(rasqgjmwmw) = dptfagkdke flehmagqwo (tdjeabzeib ) View more | - | 13 Oct 2024 | |||
Placebo | sskbgdcdln(rasqgjmwmw) = gqxwonkjsu flehmagqwo (tdjeabzeib ) View more | ||||||
Phase 3 | Ulcerative colitis, active moderate Maintenance | 369 | UPA 15 mg QD | frtwokwpeb(hunxlavpek) = mglebulugm otzuzsfhhr (xbjqfbqwog, 66.5 - 81.0) View more | Positive | 13 Oct 2024 | |
UPA 30 mg QD | frtwokwpeb(hunxlavpek) = jnndpmhglj otzuzsfhhr (xbjqfbqwog, 80.3 - 91.7) View more |