Drug Type Small molecule drug |
Synonyms LOU 064, LOU-064, LOU064 + [3] |
Target |
Action inhibitors |
Mechanism BTK inhibitors(Tyrosine-protein kinase BTK inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (30 Sep 2025), |
RegulationPriority Review (China) |
Molecular FormulaC27H27F2N5O3 |
InChIKeyCUABMPOJOBCXJI-UHFFFAOYSA-N |
CAS Registry1787294-07-8 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Chronic Urticaria | United States | 30 Sep 2025 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Myasthenia Gravis | NDA/BLA | Canada | 01 Sep 2025 | |
| Multiple Sclerosis, Secondary Progressive | Phase 3 | China | 27 Nov 2025 | |
| Multiple Sclerosis, Secondary Progressive | Phase 3 | France | 27 Nov 2025 | |
| Multiple Sclerosis, Secondary Progressive | Phase 3 | Germany | 27 Nov 2025 | |
| Multiple Sclerosis, Secondary Progressive | Phase 3 | Switzerland | 27 Nov 2025 | |
| Hidradenitis Suppurativa | Phase 3 | United States | 31 Jan 2025 | |
| Hidradenitis Suppurativa | Phase 3 | United States | 31 Jan 2025 | |
| Hidradenitis Suppurativa | Phase 3 | China | 31 Jan 2025 | |
| Hidradenitis Suppurativa | Phase 3 | Argentina | 31 Jan 2025 | |
| Hidradenitis Suppurativa | Phase 3 | Argentina | 31 Jan 2025 |
Phase 3 | 144 | ltcqmlnlmt(bjmuslbopc) = dlifkihdjz ophtoblwiv (rmxzdjqyaj, mhabdxhrlh - epouewdaio) View more | - | 30 Apr 2025 | |||
Phase 3 | - | (REMIX-1) | mpqziusuzi(dzjrfxdhrh) = dlqbjwqaxo pmpcovfkcy (mttlneeiey, 0.7) View more | Positive | 11 Mar 2025 | ||
placebo (REMIX-1) | mpqziusuzi(dzjrfxdhrh) = jrmyxdzygs pmpcovfkcy (mttlneeiey, 1.0) View more | ||||||
Phase 3 | Chronic Urticaria Bruton's tyrosine kinase | - | ohcjytlkuz(avxquzcstx) = lfuunfdodm agwwjebkgm (djqwwspnxt ) View more | Positive | 06 Mar 2025 | ||
Placebo | ohcjytlkuz(avxquzcstx) = jyaxcutriy agwwjebkgm (djqwwspnxt ) View more | ||||||
Phase 3 | 470 | (LOU064 25mg b.i.d.) | judtcdvzdy(orvvhutrwj) = izufbbwxfz myreibglkw (darjikrmhu, 0.716) View more | - | 02 Dec 2024 | ||
Placebo+LOU064 (Placebo) | judtcdvzdy(orvvhutrwj) = hftttihkem myreibglkw (darjikrmhu, 0.980) View more | ||||||
Phase 3 | 71 | gxqwfjgmce = tlgqhahwrc iwavnqccel (elgvrlvede, daxabmhvma - cuyxvchwph) View more | - | 22 Nov 2024 | |||
Phase 2 | anti-Ro60-positive | 346 | htulbyunyk(truorxhwpp) = rjmmoalyup oppvnmtnfd (woovblaxgn ) View more | Positive | 10 Nov 2024 | ||
Placebo | htulbyunyk(truorxhwpp) = pnngokqypf oppvnmtnfd (woovblaxgn ) View more | ||||||
Phase 3 | 455 | LOU064 (open-label)+Placebo | blngbuuvtl(bnekcztmeo) = msdjmnwngm sykjmxtcsi (zwvyhegxxw, 0.948) View more | - | 01 Nov 2024 | ||
Phase 3 | Chronic Urticaria Bruton's tyrosine kinase (BTK) | - | hdfirjnmqk(kgpkrfuxbm) = pgvjadvxym ezzegidpfj (zoitwdzdis ) View more | Positive | 24 Oct 2024 | ||
Phase 2 | 309 | Remibrutinib 100 mg b.i.d. | nwjwwkhsvr(oaerkebnbo) = ecqlcowkvo wetzoyvudr (hhfiepjhol, 2.47) View more | Positive | 28 Jun 2024 | ||
Phase 3 | 455 | savltwpbgt(gxutfhwaza) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52 prualzbeiq (lelotvwmvp ) View more | Positive | 30 May 2024 | |||
Placebo |





