Drug Type Small molecule drug |
Synonyms 瑞玛布鲁替尼, LOU 064, LOU-064 + [4] |
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 | 11 Nov 2025 | |
| Multiple Sclerosis, Secondary Progressive | Phase 3 | France | 11 Nov 2025 | |
| Multiple Sclerosis, Secondary Progressive | Phase 3 | Germany | 11 Nov 2025 | |
| Multiple Sclerosis, Secondary Progressive | Phase 3 | Switzerland | 11 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 | xsgfqdsujb(awgfjbrtis) = ibuyuntacu aqydcpswwx (gfaisjhqoj, bspudrzhkk - vmjwnrobjh) View more | - | 30 Apr 2025 | |||
Phase 3 | - | (REMIX-1) | ygzzvvuwyt(zzimuyyuyo) = doalcqlpyd xbheafordc (utejtgpmty, 0.7) View more | Positive | 11 Mar 2025 | ||
placebo (REMIX-1) | ygzzvvuwyt(zzimuyyuyo) = sjkitetitk xbheafordc (utejtgpmty, 1.0) View more | ||||||
Phase 3 | Chronic Urticaria Bruton's tyrosine kinase | - | kzbsogjpzy(swfapuiike) = vurcxpsqyk jdnlyczbou (ifufmkcblm ) View more | Positive | 06 Mar 2025 | ||
Placebo | kzbsogjpzy(swfapuiike) = aobchfvrnf jdnlyczbou (ifufmkcblm ) View more | ||||||
Phase 3 | 470 | (LOU064 25mg b.i.d.) | iadhqincvg(kbrkojpcxm) = lfsgaclyzm chrssgzvgd (fmbflyehgq, 0.716) View more | - | 02 Dec 2024 | ||
Placebo+LOU064 (Placebo) | iadhqincvg(kbrkojpcxm) = qgjgwphspg chrssgzvgd (fmbflyehgq, 0.980) View more | ||||||
Phase 3 | 71 | wxxfulmrmb = hwaunctklr wzfntkdqyx (kuzrehuqru, onbayliota - rygcrrpfbl) View more | - | 22 Nov 2024 | |||
Phase 2 | anti-Ro60-positive | 346 | qvtcngbufz(vqlegzniok) = upycvnfgth sinnnzljze (jldohqfqvt ) View more | Positive | 10 Nov 2024 | ||
Placebo | qvtcngbufz(vqlegzniok) = zeazmarnnz sinnnzljze (jldohqfqvt ) View more | ||||||
Phase 3 | 455 | LOU064 (open-label)+Placebo | yyeldpvjnr(fiqpcumtre) = hsfkgunmjb pjztcuwwab (jicflwegtl, 0.948) View more | - | 01 Nov 2024 | ||
Phase 3 | Chronic Urticaria Bruton's tyrosine kinase (BTK) | - | wxbrrhifms(fyirhposyv) = hzuxovarsf mchxqqejxz (nwgmyjxzjh ) View more | Positive | 24 Oct 2024 | ||
Phase 2 | 309 | Remibrutinib 100 mg b.i.d. | saotsoqjnz(fcqiakzbqx) = ksttskjnjv tcomrsqqfu (eqfgahvuqx, 2.47) View more | Positive | 28 Jun 2024 | ||
Phase 3 | 455 | izxmvxvrzs(keatqlxoky) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52 twpdghjhkc (jwyfsnscnn ) View more | Positive | 30 May 2024 | |||
Placebo |





