A Phase 3, 16-Week, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Lorecivivint 0.07 mg Dose in the Target Knee Joint of Subjects With Moderate to Severe Osteoarthritis Pain of the Knee

This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (IA) into the target (most painful) knee joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. This study will utilize standard outcomes to evaluate the safety and efficacy of lorecivivint.

Start Date18 Nov 2022

Sponsor / Collaborator

Biosplice Therapeutics, Inc.

[+1]

NCT04931667

/ TerminatedPhase 3

A 3-Year, Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Intra-articular Lorecivivint in Subjects With Osteoarthritis of the Knee in a Real-World Setting (STRIDES-EXTRA)

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 osteoarthritis of the knee in a real-world setting.

Start Date15 Jul 2021

Sponsor / Collaborator

Biosplice Therapeutics, Inc.

NCT04598542

/ CompletedPhase 1

Open-Label, Parallel-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Corticosteroid Intra Articular Injection Given 7 Days Before or 7 Days After Lorecivivint Intra-articular Injection Into the Knee of Healthy Volunteers

This study will be an open-label, parallel-arm study to determine if a prior intra-articular (IA) injection of lorecivivint (LOR) affects the safety, tolerability, and/or pharmacokinetics (PK) of a subsequent IA injection of the corticosteroid triamcinolone acetonide (TA) into the same knee, and to determine if a prior IA injection of TA affects the safety or tolerability of a subsequent IA injection of LOR into the same knee.

Start Date13 Oct 2020

Sponsor / Collaborator

Biosplice Therapeutics, Inc.

100 Clinical Results associated with Lorecivivint

100 Translational Medicine associated with Lorecivivint

100 Patents (Medical) associated with Lorecivivint

Literatures (Medical) associated with Lorecivivint

01 May 2025·RHEUMATOLOGY

Impact of structural severity on outcomes in knee osteoarthritis: an analysis of data from phase 2 and phase 3 lorecivivint clinical trials

Review

Author: Swearingen, Christopher ; McAlindon, Timothy ; Kennedy, Sarah ; Yazici, Yusuf ; Tambiah, Jeyanesh

Abstract:

Objective:

Developing knee osteoarthritis (OA) treatments is challenging due to assessing pain and joint structure outcomes within a highly heterogeneous disease. Lorecivivint (LOR), an intra-articular CLK/DYRK inhibitor, modulates Wnt and inflammatory pathways. This review analysis of LOR 0.07 mg trial data aims to describe the potential impact of baseline joint structure on OA pain response.

Methods:

Two Phase 2 and two Phase 3 trials enrolled knee OA patients with Kellgren-Lawrence (KL) Grades 2–3 and Pain Numeric Rating Scale [NRS (0–10)] ≥ 4 to ≤8 in their target knee. Cumulative frequency distribution plots by KL grade summarized the percentages of patients with medial joint space width (medial JSW) < 3 mm. Osteoarthritis Research Society International Joint Space Narrowing grades and treatment responses in trials capturing Pain NRS were similarly summarized. Pain outcome changes were estimated using baseline adjusted ANCOVA.

Results:

Compared with phase 2 trials, the phase 3 trials had an increased proportion of patients with baseline medial JSW <3 mm. LOR demonstrated beneficial treatment effects vs placebo in KL 2 subgroups, which were found to have higher proportions of baseline medial JSW >3 mm, apart from one Phase 3 trial with advanced structural knee OA.

Conclusion:

Baseline medial JSWs were heterogeneous across trials despite KL inclusion criteria. LOR demonstrated greater symptomatic improvements in patients with less structurally advanced disease, indicative of an association between OA structural damage and pain. Early treatment interventions may improve outcomes and provide insight for future OA trial inclusion criteria development.

Trial registration:

OA-02, NCT02536833; OA-04, NCT03122860; OA-10, NCT04385303; OA-11, NCT03928184.

01 Feb 2025·Heliyon

Retraction notice to “Effect of lorecivivint on osteoarthritis: A systematic review and meta-analysis” [Heliyon 9 (2023) e18682]

Article

Author: Kou, Haiyang ; Sun, Xiangxiang ; Guo, Hao ; Chen, Xinlin ; Ma, Jianbing ; Zhi, Liqiang ; Wang, Jianpeng ; Zhao, Guanghui ; Qing, Zhong ; Zhang, Rui

[This retracts the article DOI: 10.1016/j.heliyon.2023.e18682.].

01 Feb 2025·Rheumatology and Therapy

Evaluation of Safety and Efficacy of a Single Lorecivivint Injection in Patients with Knee Osteoarthritis: A Multicenter, Observational Extension Trial

Article

Author: Simsek, Ismail ; Tambiah, Jeyanesh R S ; Swearingen, Christopher J ; Kennedy, Sarah ; Yazici, Yusuf ; Ghandehari, Heli

INTRODUCTION:

Lorecivivint (LOR), a CDC-like kinase/dual-specificity tyrosine kinase (CLK/DYRK) inhibitor thought to modulate inflammatory and Wnt pathways, is being developed as a potential intra-articular knee osteoarthritis (OA) treatment. The objective of this trial was to evaluate long-term safety of LOR within an observational extension of two phase 2 trials.

METHODS:

This 60-month, observational extension study (NCT02951026) of a 12-month phase 2a trial (NCT02536833) and 6-month phase 2b trial (NCT03122860) was administratively closed after 36 months as data inferences became limited. Participants received a single intra-articular LOR or placebo (PBO) injection at their parent-trial baseline. The primary outcome was the comparative incidence of serious adverse events (SAEs), with AEs and similar safety measures comprising secondary outcomes. A post hoc baseline-adjusted analysis of covariance (ANCOVA) compared changes from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Function subscores and medial joint space width (JSW) between LOR 0.07 mg and PBO groups in a subpopulation of participants with unilateral knee pain and widespread pain low enough to allow participants to differentiate their target knee pain.

RESULTS:

The safety analysis set for the extension study included 495 LOR-treated and 208 control participants, with 409 (82.6%) and 175 (84.1%) remaining at study close, respectively. There were 68 SAEs reported in 38 (5.4%) patients; none were considered treatment-related by investigators. The incidence of AEs was similar between groups. In the post hoc subgroup efficacy analyses, LOR 0.07 mg demonstrated greater mean improvements from baseline compared with PBO in WOMAC pain and function scores out to 12 months post-injection. No between-group differences in medial JSW were observed out to 18 months.

CONCLUSIONS:

LOR appeared generally safe and well tolerated. Efficacy analyses on the subset of completer patients demonstrated durable symptom improvements in WOMAC pain and function for at least 12 months compared to PBO after a single injection of LOR.

CLINICAL TRIAL REGISTRATION NUMBER:

NCT02951026.

News (Medical) associated with Lorecivivint

06 Jan 2026

·www.biospace.com

Biosplice Announces the Submission of its New Drug Application (NDA) to the FDA for Lorecivivint (LOR) to Treat Knee Osteoarthritis

LOR is the first drug candidate with disease-modifying potential for osteoarthritis submitted for approval, demonstrating statistically and clinically significant improvements in pain, function and medial joint space width when compared with placebo, along with very good safety SAN DIEGO, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering first-in-class therapeutics based on small-molecule inhibition of CLK/DYRK kinases, announced today that it has submitted its NDA to the FDA for approval of its novel therapy for the treatment of knee osteoarthritis (“OA”). Biosplice’s drug candidate, lorecivivint (“LOR”), is a small-molecule suspension intended to be injected 1-2 times per year into the knee joint. LOR, evaluated in 11 clinical trials, significantly improved pain and function in patients with a very good safety profile. Results from Biosplice’s Phase 3 OA-07 trial also showed that LOR led to improvements in medial joint space width (JSW) on imaging over multiple years. These results support LOR’s potential as the first disease-modifying therapy for OA, a milestone long sought by patients, physicians and researchers. In the 2-year Phase 3 OA-07 study, patients dosed with LOR significantly improved their pain at 6 months and both pain and function at 12 months, compared to placebo. Similar improvements were also seen in Phase 2 trials, confirming the symptomatic benefit of LOR in OA patients. The figure below shows pain scores, which historically represented the primary approval endpoint for OA with the FDA, from Biosplice’s OA-07 study. Beyond symptom relief, OA-07 demonstrated joint structure benefits rarely observed in OA research: patients treated with LOR in the OA-07 study, maintained and ultimately improved their medial JSW, as measured by X-ray at two years following annual injections. Placebo patients who decreased their medial JSW in the first year of OA-07, once crossed over to active treatment with LOR, also showed increases in medial JSW following cross-over. Erich Horsley, CEO of Biosplice, commented, “After over a decade of clinical trials, we are pleased to be the first company to submit a data package in the US for a potentially disease-modifying drug in knee OA for approval. As many knee OA patients are aware, the patient journey for someone diagnosed with OA is currently painful and disheartening. We are excited about the prospects of materially improving the OA patient’s journey with a new treatment that is both safe and effective and has the potential to delay further structural progression.” Dr. Yusuf Yazici, Chief Medical Officer of Biosplice, continued, “Once approved, LOR promises to bring near-term pain relief and long-term structural benefit to 25 million American knee OA patients. We are particularly excited by LOR’s safety profile, which is similar to placebo across over 1,800 patients dosed, while demonstrating significant improvement in pain, function and structure.” Biosplice has been developing LOR for over a decade and initially synthesized and identified the novel compound in 2011. LOR is a small-molecule drug which selectively inhibits two kinases, DYRK1A and CLK2. DYRK1A is an inflammatory kinase, the inhibition of which results in significant reductions in multiple inflammatory cytokines and catabolic enzymes which break down hyaline cartilage. CLK2 alters local Wnt pathway signaling, which is believed to promote chondrocyte formation and the protection of hyaline cartilage. Any new drug application in OA must be supported by a good safety profile. Throughout the decade-long clinical development program, LOR’s safety pro been consistent with and similar to that of placebo. LOR’s safety is enhanced by the fact that, when injected into the knee joint, the drug has no detectible systemic exposure throughout the body. Professor Tim McAlindon, from UMass Chan School of Medicine, who has advised Biosplice and has been involved in the development program for LOR, commented, “It is rare to see a drug with LOR’s safety profile, to say nothing of its disease-modifying potential. The unmet need in OA is well-known, and patients have not had access to novel treatments in decades. The approval of LOR would potentially be a remarkable development for OA patients.” Seth Ginsberg, Co-Founder and President of Global Healthy Living Foundation and CreakyJoints, amplifies the voices of millions of arthritis patients through the efforts of his organization. He commented, “Osteoarthritis affects more than 50 million Americans and remains one of the leading causes of pain, disability, and loss of independence worldwide. For patients, the disease shapes daily decisions, careers and quality of life, often over many years, while meaningful progress that addresses the disease itself rather than symptoms alone has remained out of reach. For these reasons, an approval of LOR could be immensely impactful for OA patients.” About Osteoarthritis Osteoarthritis (OA), the most common form of arthritis, is a serious chronic disease that affects an estimated 50 million U.S. adults and over 500 million adults globally 1 . OA is the most prevalent joint disease and a leading source of chronic pain and disability in the United States. OA may affect the knees, hips, shoulders, hands, spine, or great toes; current estimates indicate that there are about 25 million, 1 in 10 U.S. adults, with knee OA alone in the US i . While often considered a disease of old age, approximately half of symptomatic knee OA diagnoses occur by the age of 55. 2 Those who live with OA experience pain, stiffness, and swelling, which limits their function and mobility, often impacting their daily lives. Functional limitations are present in about 80% of people with OA, and 25% are unable to perform major activities of daily living 3 . Mortality is higher in patients with knee and hip OA largely due to cardiovascular disease, with a higher risk of death associated with severity of walking disability 4 . Given both the increased morbidity and mortality, the US FDA has accepted knee OA as a ‘serious condition’. About Lorecivivint (LOR) Lorecivivint is a small-molecule suspension drug intended to be injected into the intra-articular knee joint space for the treatment of OA. LOR has been tested as a once-per-year or every-six-month injection in Biosplice’s development program. LOR’s mechanism of action is based on selective and potent inhibition DYRK1A and CLK2 kinases. DYRK1A inhibition has been shown to reduce inflammation and catabolic enzymes, and inhibition of CLK2 is believed to provide cartilage protective and regenerative properties. The extensive clinical development program for LOR has provided evidence for statistically and clinically significant improvement in pain, function and medial JSW with a very good safety profile. LOR has not yet been approved by the FDA. About Biosplice Biosplice is developing first-in-class, small-molecule therapeutics based on novel biology linking CLK/DYRK kinases to the therapeutic regulation of alternative splicing. Biosplice strives for disease-modifying solutions in all of its drug candidates. Biosplice’s drug candidates in development include lorecivivint for osteoarthritis (in NDA stage), and, through its majority-owned subsidiary, TenaRx, programs in oncology, diabetes and neurology. Learn more at . Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the review and potential approval of Biosplice’s New Drug Application for lorecivivint and the therapeutic potential of lorecivivint. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, uncertainties inherent in the regulatory review process and other risks associated with drug development and commercialization. Biosplice undertakes no obligation to update or revise any forward-looking statements contained herein, whether as a result of new information, future events, or otherwise. Corporate Contact: Phil Wilson, CFO Biosplice Therapeutics, Inc. phil.wilson@biosplice.com 1 IFHMaE. 2021. ‘GBDx Results Tool,’ IHME, University of Washington, Accessed January 7, 2021. 2 Losina E, et al. Arthritis Care Res (Hoboken). 2013. 3 Neogi T. Osteoarthritis Cartilage. 2013. 4 Osteoarthritis Research Society (OARSI). Osteoarthritis: A Serious Disease. Published December 1, 2016. Accessed June 25, 2024. Photos accompanying this announcement are available at:

Clinical ResultNDAPhase 2Phase 3

22 Dec 2025

·www.globenewswire.com

Biosplice Therapeutics Announces First Patient Dosed in Investigator‑Initiated Phase 1 Clinical Trial of Cirtuvivint and Olaparib in BRCA/HRD Platinum‑Resistant Ovarian Cancer

Study at the University of Colorado Anschutz Cancer Center builds on preclinical data showing that cirtuvivint plus PARP inhibition overcame resistance in preclinical models of high‑grade serous ovarian cancerSAN DIEGO, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company advancing small-molecule inhibition of CDC-like kinases (CLK) and dual-specificity tyrosine phosphorylation-regulated (DYRK) kinases, today announced that the first patient has been dosed in a Phase 1 clinical trial evaluating cirtuvivint in combination with olaparib in women with BRCA-mutated and/or homologous recombination-deficient (HRD) platinum-resistant ovarian cancer. The investigator-initiated trial, “Cirtuvivint and Olaparib for the Treatment of Patients with BRCA/HRD Platinum Resistant Ovarian Cancer” (NCI-2024-09126; NCT06856499), is sponsored by UCHealth University of Colorado Hospital and led by principal investigator Bradley R. Corr, MD, associate professor and director of clinical research in gynecologic oncology at the University of Colorado Anschutz. This open-label Phase 1 study uses a dose-escalation design followed by a dose-expansion cohort. Its primary objectives are to assess the safety and tolerability of the cirtuvivint–olaparib combination and to determine a recommended Phase 2 dose and regimen in women with BRCA/HRD platinum-resistant ovarian cancer who have previously received a PARP inhibitor. “Dosing the first patient in this trial marks an important next step for cirtuvivint’s development and for patients living with therapy-resistant ovarian cancer,” said Yusuf Yazici, MD, Chief Medical Officer of Biosplice. “Preclinical work from Dr. Corr, Dr. Bitler and colleagues at CU Anschutz suggests that cirtuvivint can disrupt key resistance pathways and work synergistically with PARP inhibition. We’re pleased to support this fully oral, targeted combination as it enters the clinic for women who urgently need additional options.” The trial is the clinical culmination of a preclinical research program conducted at CU Anschutz, recently published in Cancer Research Communications. In that work, Corr, Bitler and collaborators showed that SM08502 (cirtuvivint), a pan-CLK/DYRK inhibitor, indirectly suppresses WNT/TCF signaling—a pathway that tumor cells can switch on as a “backup survival system” to escape the effects of PARP inhibitors. In multiple BRCA-mutated and HRD high-grade serous ovarian cancer models that were resistant to PARP inhibitors, cirtuvivint: Inhibited WNT/TCF transcriptional activity and reduced nuclear β-cateninInduced DNA damage and reduced tumor cell viabilitySynergized with olaparib to slow tumor progression and extend survival in both immune-intact and immune-compromised in vivo modelsFavorably remodeled features of the tumor immune microenvironment, including reductions in immune-suppressive PD-1/PD-L1–expressing cells Taken together, these preclinical studies provide strong rationale to test the cirtuvivint–olaparib combination clinically as a strategy to overcome or delay PARP inhibitor resistance in ovarian cancer. “Many of our patients initially benefit from PARP inhibitors but then face the devastating reality of resistance,” said Dr. Corr. “Our laboratory work pointed us toward WNT signaling as a critical escape route for these tumors. By pairing cirtuvivint with olaparib, this trial aims to shut down both DNA repair and that backup survival pathway, with the hope of restoring sensitivity in women whose cancers have stopped responding.” Cirtuvivint is a selective pan-CLK, pan-DYRK inhibitor that modulates alternative RNA splicing, including transcripts involved in oncogenic pathways. Preclinical studies have shown that CLK/DYRK inhibition alters splice patterns in malignant cells, suppresses oncogenic variants, and enhances apoptosis. In addition to the trial in platinum-resistant ovarian cancer, cirtuvivint is being evaluated in several other clinical trials sponsored and funded by collaborating partners: An ongoing Phase 2 trial in advanced soft tissue sarcomas (EUCT 2024-511987-10-00; NCT07032285) in collaboration with SELNETAn ongoing Phase 1 trial in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) (NCT06484062) in collaboration with the National Cancer InstituteAn upcoming combination trial with irinotecan in relapsed small-cell lung cancer (NCT07155200) in collaboration with Washington University School of Medicine About CirtuvivintCirtuvivint is a small molecule inhibitor of CLK and DYRK kinases, which are increasingly recognized as key drivers of various cancers. By targeting these kinases, cirtuvivint modulates alternative pre-mRNA splicing, which reduces the expression of genes vital for tumor growth, survival, and drug resistance. The compound has shown broad anti-tumor activity across a range of solid and liquid tumors in extensive preclinical studies. Cirtuvivint has also been investigated for the treatment of advanced solid tumors in two clinical trials. The first, SM08502-ONC-01 (NCT03355066), was a first-in-human dose escalation study designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with advanced solid tumors. The second, SM08502-ONC-03 (NCT05084859), was a Phase 1b trial assessing the efficacy of cirtuvivint in combination with standard treatments for patients with advanced castration-resistant prostate cancer, advanced non-small cell lung cancer, and advanced colorectal cancer. About BiospliceBiosplice stands at the forefront of research concentrating on the study and regulation of Cdc2-like kinases (CLKs) and dual-specificity tyrosine-regulated kinases (DYRKs). These kinases play pivotal roles in cell cycle regulation, splicing, and neurodevelopment, marking them as critical targets for therapeutic intervention in a range of diseases, including osteoarthritis, cancer, neurological disorders, and diabetes. With a robust chemical platform for kinase inhibition and a deep understanding of kinase signaling pathways, Biosplice leverages cutting-edge technologies to discover and develop highly selective kinase inhibitors. Biosplice’s drugs in clinical development include lorecivivint for knee osteoarthritis (completed Phase 3) and cirtuvivint for numerous cancers, with a broad preclinical pipeline that encompasses Alzheimer’s disease, diabetes, and other degenerative conditions. Learn more at https://www.biosplice.com Corporate Contact: Phil Wilson phil.wilson@biosplice.com

Phase 1Phase 2Phase 3

11 Sep 2025

·www.globenewswire.com

Biosplice Therapeutics Announces First Patient Dosed in NCI-Sponsored Clinical Trial of Cirtuvivint in Acute Myeloid Leukemia and Myelodysplastic Syndromes

Sept. 09, 2025 -- Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering advancements in small molecule inhibition of CDC-like kinases (CLK) and Dual-specificity tyrosine phosphorylation-regulated (DYRK) kinases, today announced that the first patient has been dosed in a Phase 1 clinical trial of cirtuvivint in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The study is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and conducted by the NCI funded Experimental Therapeutics Clinical Trials Network, under a Cooperative Research and Development Agreement (CRADA) with Biosplice. This milestone highlights the ongoing collaboration between Biosplice and the NCI’s Cancer Therapy Evaluation Program (CTEP). The trial (NCT06484062) is evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of cirtuvivint, both as a monotherapy and in combination with ASTX727 (INQOVI, oral decitabine/cedazuridine), a hypomethylating agent developed by Taiho Oncology, Inc. and FDA-approved for MDS. The study is enrolling patients with relapsed or refractory AML or MDS, and is led by Principal Investigator Dr. Evan Chen at Dana-Farber Cancer Institute. “We are pleased to see continued momentum in cirtuvivint’s development with this important milestone in our collaboration with the NCI,” said Yusuf Yazici, M.D., Chief Medical Officer at Biosplice. “AML and MDS remain areas of significant unmet need, and we are hopeful that cirtuvivint’s unique mechanism, modulating RNA splicing to disrupt oncogenic signaling, will demonstrate benefit for patients with these challenging malignancies. The combination with a well-established agent such as ASTX727 offers a compelling approach to enhancing therapeutic response.” Cirtuvivint is a selective pan-CLK, pan-DYRK inhibitor that modulates alternative RNA splicing, including transcripts involved in oncogenic pathways. Preclinical studies have shown that CLK/DYRK inhibition alters splice patterns in malignant cells, suppresses oncogenic variants, and enhances apoptosis. The combination with ASTX727 aims to leverage two complementary mechanisms, hypomethylation (ASTX727) and splicing modulation (cirtuvivint), to target leukemic cells more effectively.、 In addition to the NCI-sponsored AML/MDS trial, cirtuvivint is being evaluated in several other clinical programs: An ongoing Phase 2 trial in advanced soft tissue sarcomas (NCT05633307) An upcoming combination trial with olaparib in BRCA-mutated or homologous recombination-deficient platinum-resistant ovarian cancer (NCT06856499) An upcoming combination trial with irinotecan in relapsed small-cell lung cancer (NCT07155200) Cirtuvivint is a small molecule inhibitor of CLK and DYRK kinases, which are increasingly recognized as key drivers of various cancers. By targeting these kinases, cirtuvivint modulates alternative pre-mRNA splicing, which reduces the expression of genes vital for tumor growth, survival, and drug resistance. The compound has shown broad anti-tumor activity across a range of solid and liquid tumors in extensive preclinical studies. Cirtuvivint has also been investigated for the treatment of advanced solid tumors in two clinical trials. The first, SM08502-ONC-01 (NCT03355066), was a first-in-human dose escalation study designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with advanced solid tumors. The second, SM08502-ONC-03 (NCT05084859), was a Phase 1b trial assessing the efficacy of cirtuvivint in combination with standard treatments for patients with advanced castration-resistant prostate cancer, advanced non-small cell lung cancer, and advanced colorectal cancer. Biosplice stands at the forefront of research concentrating on the study and regulation of Cdc2-like kinases (CLKs) and dual-specificity tyrosine-regulated kinases (DYRKs). These kinases play pivotal roles in cell cycle regulation, splicing, and neurodevelopment, marking them as critical targets for therapeutic intervention in a range of diseases, including osteoarthritis, cancer, neurological disorders, and diabetes. With a robust chemical platform for kinase inhibition and a deep understanding of kinase signaling pathways, Biosplice leverages cutting-edge technologies to discover and develop highly selective kinase inhibitors. Biosplice’s drugs in clinical development include lorecivivint for knee osteoarthritis (completed Phase 3) and cirtuvivint for numerous cancers, with a broad preclinical pipeline that encompasses Alzheimer’s disease, diabetes, and other degenerative conditions. The content above comes from the network. if any infringement, please contact us to modify.

Clinical Study

100 Deals associated with Lorecivivint

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis, Knee	NDA/BLA	United States	Biosplice Therapeutics, Inc.	06 Jan 2026
Intervertebral Disc Degeneration	Phase 1	United States	Biosplice Therapeutics, Inc.	26 Jul 2017
Osteoarthritis, Hip	Preclinical	United States	Biosplice Therapeutics, Inc.	17 Jul 2023
Shoulder arthritis	Preclinical	United States	Biosplice Therapeutics, Inc.	17 Jul 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04520607 (OA-07, ACR2025)	Phase 3	Osteoarthritis, Knee	276	Lorecivivint	jjfahlugem(ytaorajhrb) = krgjeitjfw wszrarogrq (rusijvakmk ) View more	Positive	24 Oct 2025
				Placebo	jjfahlugem(ytaorajhrb) = pcvviarxhs wszrarogrq (rusijvakmk ) View more
NCT04520607 (OA-07, ACR2025)	Phase 3	Osteoarthritis, Knee	501	Lorecivivint	ynujkhdzxw(xerczkntjc): Difference = -4.86 (95.0% CI, -9.36 to -0.35), P-Value = 0.035 View more	Positive	24 Oct 2025
				Placebo
NCT04520607 (OA-07, ACR2024)	Phase 3	Osteoarthritis, Knee	276	Lorecivivint 0.07 mg	fhmgccrjsq(tnfdsxsuge) = tzkfrjtfga fnicryknjf (fryfjmiqpg ) View more	Positive	10 Nov 2024
				Placebo	fhmgccrjsq(tnfdsxsuge) = dwimsgptwy fnicryknjf (fryfjmiqpg ) View more
NCT04520607 (OA-07, ACR2024)	Phase 3	Osteoarthritis, Knee	276	Lorecivivint 0.07 mg	ijtybhypuo(hnnjojflbr) = At Visit 6E, 36 months after first injection, this loss was statistically significant compared to the last available PBO measure prior to crossover assuming a) no change (∆ = 0.22 mm, conservative scenario [P=0.001]) and b) progression (∆ = 0.38 mm, realistic scenario [P< 0.001]) zynailwlpj (elftybrwcn ) View more	Positive	10 Nov 2024
				Placebo
NCT02536833 (OA-02, ACR2024)	Phase 2	Osteoarthritis, Knee	354	Lorecivivint	zqvbsthtvi(kkqixjcglu): Difference = 6.06 View more	Positive	10 Nov 2024
				Placebo
NCT04520607 (OA-07, EULAR 12024 \| EULAR 22024) Manual	Phase 3	Osteoarthritis, Knee	276	Lorecivivint	lakgveukyl(hltkmfyvhq) = gkshmjebvd mekrrmzuwt (sbvrfxlygn, 0.05)	Positive	14 Jun 2024
				Placebo	lakgveukyl(hltkmfyvhq) = lpmhfpgnvm mekrrmzuwt (sbvrfxlygn, 0.05)
NCT04520607 (OA-07, EULAR 12024 \| EULAR 22024) Manual	Phase 3	Osteoarthritis, Knee	276	Lorecivivint	sciidfbseo(qvzvmbrvpq) = yzeehltspy mcnfjqhshc (ncjdcpumou, 2.0) View more	Positive	14 Jun 2024
				Placebo	sciidfbseo(qvzvmbrvpq) = apnwgsbegp mcnfjqhshc (ncjdcpumou, 2.1) View more
NCT05603754 (STRIDES, NEWS)	-	Arthropathy of knee joint \| Osteoarthritis, Knee	496	Lorecivivint	oxzhgltrax(zdmulzuchi) = not reached the endpoint rhxrzdvkxr (uywgvueeae )	Negative	18 Apr 2024
				安慰剂
NCT03928184 (OA-07, WCO_IOF_ESCEO2024)	Phase 3	Osteoarthritis, Knee	276	Lorecivivint 0.07 mg	ttidyahyjz(ewkmjfdbjm) = zetvccuidz huiwfmzdoy (avldgzsdzp, 0.05)	Positive	11 Apr 2024
				Placebo	ttidyahyjz(ewkmjfdbjm) = kzhukbhpfd huiwfmzdoy (avldgzsdzp, 0.05)
NCT03928184 \| NCT04520607 (OA-07, GlobeNewswire) Manual	Phase 3	Osteoarthritis, Knee	-	Lorecivivint	rzjqtfwjyh(lsjswvnfwf) = lorecivivint continued to appear safe and well-tolerated, with no additional safety signals with repeat injections. wiyiufzptf (rxbzagihpx ) View more	Positive	13 Nov 2023
				placebo

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