Drugs / Lorecivivint
last change May 2025 re-read 8 days ago

Lorecivivint

also known as LOR · SM04690 · Adavivint

Small molecule targets CLK2, DYRK1A via inhibition

Developed for
osteoarthritis, knee · intervertebral disk degenerative disorder · osteoarthritis
Investigated by
Biosplice Therapeutics, Inc. · NBCD A/S

Trials 12

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT04598542 Oct → Dec 2020 — Biosplice Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT03246399 Jul 2017 → Nov 2018 intervertebral disk degenerative disorder Biosplice Therapeutics, Inc. Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT02095548 Mar 2014 → Sep 2015 — Biosplice Therapeutics, Inc. Completed No outcome recorded
Phase 24 trials · 2 missed
Phase 2 NCT03706521 Mar 2019 → Jul 2020 osteoarthritis, knee Biosplice Therapeutics, Inc. Terminated No outcome recorded
Phase 2 NCT03727022 Nov 2018 → Sep 2020 osteoarthritis, knee Biosplice Therapeutics, Inc. Completed Missed primary
Phase 2 NCT03122860 Apr 2017 → Apr 2018 osteoarthritis, knee Biosplice Therapeutics, Inc. Completed Mixed
Phase 2 NCT02536833 Sep 2015 → Apr 2017 osteoarthritis Biosplice Therapeutics, Inc. Completed Missed primary
Phase 35 trials · 2 missed
Phase 3 NCT05603754 Nov 2022 → Feb 2024 osteoarthritis, knee Biosplice Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT04931667 Jul → Dec 2021 osteoarthritis, knee Biosplice Therapeutics, Inc. Terminated No outcome recorded Stop: Business
Phase 3 NCT04520607 Aug 2020 → Jun 2023 osteoarthritis, knee Biosplice Therapeutics, Inc. Terminated Mixed
Phase 3 NCT04385303 May 2020 → Sep 2021 osteoarthritis, knee Biosplice Therapeutics, Inc. Completed Missed primary
Phase 3 NCT03928184 May 2019 → Aug 2021 osteoarthritis, knee Biosplice Therapeutics, Inc. Completed Missed primary

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2021-07-22 Biosplice Therapeutics, Inc. Results Biosplice Publishes Phase 2B Lorecivivint Analysis Showing Clinically Meaningful Benefits to Knee Osteoarthritis Patients biosplice.com ↗
Biosplice showed that study subjects dosed with 0.07 mg lorecivivint were over two times more likely to meet the criteria for OMERACT-OARSI Strict Response, a measure that includes 50% improvement in pain or function, than those on placebo at 12 weeks.
2021-04-26 Biosplice Therapeutics, Inc. Results Biosplice Publishes Successful Clinical Trial in Knee Osteoarthritis biosplice.com ↗
In this 24-week clinical trial, Biosplice’s groundbreaking knee OA drug candidate, lorecivivint, met primary endpoints of Pain NRS (daily pain measurement) at both 12 and 24-week timepoints.
2020-05-22 Biosplice Therapeutics, Inc. Results Biosplice Announces Publication of Phase 2 Data on Lorecivivint, Now in Pivotal Trials for Knee Osteoarthritis biosplice.com ↗

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 17 sources stand behind the page.

FieldValueCited text
Known as Lorecivivint “OBJECTIVE: To assess the safety and efficacy of a novel Wnt pathway modulator, lorecivivint (SM04690), for treating pain and inhibiting structural progression in moderately to...” PMID 32432388 ↗ Sep 2020
8

“Lorecivivint (LOR; SM04690), an investigational Wnt pathway modulator” PMID 33588087 ↗ Feb 2021

NCT05603754 ↗

NCT03706521 ↗

NCT04598542 ↗

NCT04931667 ↗

NCT03928184 ↗

NCT04385303 ↗

NCT04520607 ↗

Known as Adavivint ChEMBL registry synonym — accepted as the source's own label CHEMBL4297639 ↗
Known as LOR “This phase 2 study was a single center, open-label study of lorecivivint (LOR) (internal identification SM04690) injected intraarticularly (IA) into the target knee (most...” NCT03706521 ↗
4

“This study is designed as a 3-year, multicenter, open-label study evaluating the safety, tolerability, and efficacy of intra-articular (IA) Lorecivivint (LOR) in subjects with...” NCT04931667 ↗

“Lorecivivint (LOR), a novel IA cdc2-Like Kinase (CLK)/Dual-Specificity Tyrosine Phosphorylation-Regulated Kinase (DYRK) inhibitor thought to modulate Wnt and inflammatory pathways” PMID 37902943 ↗ Oct 2023

“Lorecivivint (LOR), an intra-articular CLK/DYRK inhibitor, modulates Wnt and inflammatory pathways.” PMID 39495154 ↗ May 2025

“Lorecivivint (LOR; SM04690), an investigational Wnt pathway modulator” PMID 33588087 ↗ Feb 2021

Known as SM04690 “OBJECTIVE: To assess the safety and efficacy of a novel Wnt pathway modulator, lorecivivint (SM04690), for treating pain and inhibiting structural progression in moderately to...” PMID 32432388 ↗ Sep 2020
4

NCT03727022 ↗

NCT03246399 ↗

NCT03122860 ↗

NCT02095548 ↗

Action Inhibit “Dual specificity tyrosine-phosphorylation-regulated kinase 1A inhibitor” CHEMBL4297639 ↗
2

“Dual specificity protein kinase CLK2 inhibitor” CHEMBL4297639 ↗

“a novel Wnt pathway inhibitor” PMID 28711582 ↗ Jul 2017

Modality Small molecule “a potential OA treatment in development, lorecivivint, a novel small molecule thought to inhibit inflammation and a biological pathway called the Wnt pathway” PMID 37902943 ↗ Oct 2023
Route Other “knee intra-articular (IA) injection” PMID 28711582 ↗ Jul 2017
Target CLK2 “Dual specificity protein kinase CLK2 inhibitor” CHEMBL4297639 ↗
Target DYRK1A “Dual specificity tyrosine-phosphorylation-regulated kinase 1A inhibitor” CHEMBL4297639 ↗