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

This phase 3 study was 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 utilized 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

194

Literatures (Medical) associated with Lorecivivint

01 Dec 2026·TALANTA

First-derivative spectrofluorometric method based on plasmon-enhanced gold nanoparticles for rapid and ultrasensitive determination of loratadine and pseudoephedrine in human plasma and pharmaceutical dosage forms

Article

Author: Safwat, Nardine ; Magdy, Nancy ; Hassan, Marwa ; El-Kosasy, Amira M

Loratadine (LOR) and pseudoephedrine (PSE) are widely used in combination for the treatment of seasonal allergies; therefore, the development of sensitive and reliable analytical methods for their simultaneous determination is essential. In this study, highly sensitive first-derivative spectrofluorimetric method was developed for the first time to resolve the severe spectral overlap between LOR and PSE. Sensitivity was further enhanced through the incorporation of gold nanoparticles (AuNPs). LOR and PSE were selectively determined at 459.6 nm and 466.0 nm following excitation at 230.0 nm and 226.0 nm, respectively. Methanol was used as the diluting solvent with a short shaking time of 10 min after AuNPs addition. Under the optimized conditions, the method showed linear ranges of 0.8-3.5 ng/mL and 70.0-400.0 ng/mL, with detection limits of 0.26 ng/mL and 31.75 ng/mL, for LOR, and PSE; respectively. The proposed method was successfully applied for the determination of LOR and PSE in human plasma with a recovery of 99.60 ± 0.61 and 99.00 ± 0.89 and in pharmaceutical dosage forms with a recovery of 99.78 ± 1.18 and 99.83 ± 0.15; respectively.

01 Jul 2026·BIOMEDICINE & PHARMACOTHERAPY

Lorlatinib protects dopaminergic neurons by inhibiting ALK-mediated neuroinflammation in a mouse model of Parkinson’s disease

Article

Author: Leem, Yea-Hyun ; Kim, Hee-Sun ; Park, Jin-Sun ; Kim, Do-Yeon ; Kim, Seong-Eun ; Park, Jung-Eun

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by the loss of dopaminergic neurons in the substantia nigra (SN), where neuroinflammation plays a critical pathogenic role. Anaplastic lymphoma kinase (ALK) has recently emerged as a therapeutic target for inflammatory and immune disorders; however, its role in neuroinflammation and PD remains unclear. In this study, we investigated the role of ALK using the ALK-specific inhibitor lorlatinib (LOR) in a 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP)-induced mouse model of PD. LOR significantly improved motor function, attenuated dopaminergic neuronal loss, and restored neurotrophic factor expression. LOR also suppressed ALK phosphorylation and inhibited activation of the downstream STING-TBK1-IRF3/NF-κB signaling pathway in the SN. Notably, MPTP-induced p-ALK expression was predominantly colocalized with microglia, suggesting a potential role for microglial ALK in PD-related neuroinflammation. LOR consistently reduced microglial and astrocytic activation, decreased pro-inflammatory cytokine expression, and attenuated oxidative stress by activating the Nrf2 antioxidant signaling pathway. Additionally, LOR restored the blood-brain barrier integrity and suppressed T lymphocyte infiltration into the SN region. Finally, LOR attenuated the MPTP-induced apoptosis and necroptotic cell death in dopaminergic neurons. Collectively, these findings demonstrate that ALK inhibition confers neuroprotection by modulating microglia-mediated neuroinflammation. Given that LOR is a clinically approved anticancer drug with blood-brain barrier permeability, this study provides experimental evidence supporting its repositioning for the treatment of neuroinflammatory disorders, such as PD.

01 Mar 2026·Clinical Gastroenterology and Hepatology

Real-world Experience of Upadacitinib Reinduction and High-dose Maintenance Therapy in Inflammatory Bowel Disease

Article

Author: Ho, Agnes H Y ; Choi, David ; Fear, Evan ; Rubin, David T ; Krugliak Cleveland, Noa ; Pekow, Joel ; Fine, Zachary ; Cohen, Russell D ; Dalal, Sushila R ; Choi, Natalie K ; Mathew, Alex J ; McDermott, Alexandra

BACKGROUND & AIMS:

Upadacitinib (UPA) is approved for the treatment of moderately to severely active Crohn's disease (CD) or ulcerative colitis (UC). Responders to UPA 45 mg daily (QD) may lose response (LOR) after transition to lower maintenance doses. We describe our real-world experience of LOR, reinduction, and subsequent maintenance with UPA 45 mg QD.

METHODS:

This is a prospective cohort study of patients with inflammatory bowel disease (IBD) treated with UPA between April 2022 and November 2023. Included patients responded to UPA induction, had LOR after dose reduction, and subsequently received reinduction therapy with 45 mg QD. Clinical, biochemical, radiologic, and endoscopic data were collected; comparative statistics and Kaplan-Meier survival were calculated.

RESULTS:

A total of 181 patients (79 CD, 83 UC, 6 IBD-Unclassified, 13 ileal pouch anal-anastomosis) responded to UPA 45 mg QD induction and were switched to a lower maintenance dose (30 mg QD, n = 180; 15 mg QD, n = 1), 46 (16 CD, 23 UC, 1 IBD- Unclassified, 6 ileal pouch anal-anastomosis) met the above criteria. They were followed for a median duration 93 weeks (interquartile range [IQR], 62-119 weeks). Relapse occurred at a median of 21 weeks (IQR, 8-46 weeks) after dose reduction. Dose escalation to 45 mg QD for a median of 13 weeks (IQR, 8-36 weeks) recaptured clinical response in 80.4%. Among patients who recaptured response, 19 again reduced to 30 mg or 15 mg. Over a median of 40 weeks (IQR, 22-59 weeks), 93.8% of patients on 45 mg QD maintained remission vs 21.1% who again dropped to 30 mg QD (P < .001). Disease extent and duration did not significantly predict response recapture. Acne/rosacea was the most common adverse event (39%); there were no serious adverse events.

CONCLUSIONS:

Most patients with IBD who lose response to UPA when dose reduced in maintenance can be recaptured with 45 mg QD. Among these, continuing 45 mg QD for maintenance is effective, and appears safe.

News (Medical) associated with Lorecivivint

7 hours ago

·www.biospace.com

UK’s MHRA Accepts Biosplice’s Application for Lorecivivint (LOR) in Knee Osteoarthritis and Begins Assessment

LOR, the first approval-stage drug candidate with disease-modifying potential for osteoarthritis, is now under assessment in the United Kingdom, with a submission to the European Medicines Agency planned for later this month SAN DIEGO, Sept. 08, 2026 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. (“Biosplice”), a late-stage biopharmaceutical company developing lorecivivint (“LOR”), a first-in-class small-molecule inhibitor of CLK/DYRK kinases, for the treatment of knee osteoarthritis (“OA”), announced today that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) has determined Biosplice’s application for approval of LOR to be complete and valid. Acceptance of the application starts the MHRA’s formal review timetable and moves LOR into regulatory assessment in the United Kingdom. LOR is a small-molecule suspension intended to be injected 1-2 times per year into the knee joint. LOR, evaluated in eleven clinical trials, significantly improved joint structure, pain and function in patients, with a well-established safety pro all trials. Disease modification was demonstrated primarily in Biosplice’s Phase 3 OA-07 trial, which showed that LOR improved medial joint space width (JSW) on imaging over multiple years—JSW is the usual standard by which structural disease progression is clinically measured. These results support LOR’s potential to be the first disease-modifying therapy for OA, a milestone long sought by patients, physicians and researchers. Taken together, the clinical data suggest a highly positive benefit-to-risk profile. In its acknowledgement notification, the MHRA confirmed that preliminary checks of the LOR dossier have been completed, that the submission is considered valid, and that it is now ready for the start of assessment. Biosplice intends to submit an application for LOR to the European Medicines Agency (“EMA”) later this month. Erich Horsley, CEO of Biosplice, commented, “After more than a decade of clinical development and eleven clinical trials, lorecivivint is now formally under assessment in the United Kingdom. As many knee OA patients are aware, the patient journey for someone diagnosed with knee OA is currently painful and disheartening. Patients have gone decades without a meaningful new treatment option, and this assessment could be an important step towards dramatically improving the quality and duration of millions of patient lives.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Louis Tharp, Executive Director of the patient support group Global Healthy Living Foundation / CreakyJoints, added, “We hear constantly from osteoarthritis patients who await safe, innovative and potentially disease-modifying medicines to treat OA. The UK’s review of LOR for approval brings hope to millions of long-suffering patients.” More information on LOR can be found at . 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 whose medial JSW decreased during the first year of OA-07, once crossed over to active treatment with LOR, also showed increases in medial JSW following cross-over. Beyond structural improvement, the Phase 3 OA-07 study showed patients dosed with LOR significantly improved their pain scores at 6 months and both pain and function at 12 months, compared to placebo. Similar improvements in structure, pain and function were also seen in Phase 2 trials, confirming the benefit of LOR in OA patients. The figure below shows pain scores in the OA-07 study. Patient-reported pain outcomes have historically been the main approval endpoint for OA with regulatory authorities. ezstandalone.cmd.push(function () { ezstandalone.showAds(132); }); 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 that 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 that break down hyaline cartilage. CLK2 alters local Wnt pathway signaling, which is believed to promote chondrocyte formation and the protection of hyaline cartilage. Any application for the approval of a new medicine in OA must be supported by data demonstrating that it is safe. 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 detectable systemic exposure throughout the body. 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 about 25 million U.S. adults, 1 in 10, have knee OA alone 1 . Although OA is often considered a disease of old age, approximately half of symptomatic knee OA diagnoses occur by age 55. 2 ezstandalone.cmd.push(function () { ezstandalone.showAds(133); }); Those who live with OA experience pain, stiffness, and swelling, which limit 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 of 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 of statistically and clinically significant improvement in pain, function and medial JSW, with a well-established safety profile. LOR is an investigational medicine and has not been approved by the MHRA, the FDA or any other regulatory authority. About Biosplice Biosplice is a late-stage biopharmaceutical company focused on lorecivivint, a first-in-class small-molecule inhibitor of CLK/DYRK kinases being developed as a potentially disease-modifying treatment for knee osteoarthritis. Biosplice’s work is grounded in novel biology linking CLK/DYRK kinases to the therapeutic regulation of alternative splicing. Lorecivivint has been submitted for approval in the United States and is under assessment in the United Kingdom. Biosplice also holds a majority interest in TenaRx, which is developing programs in oncology, diabetes and neurology. Learn more at . Forward-Looking Statements ezstandalone.cmd.push(function () { ezstandalone.showAds(134); }); This press release contains forward-looking statements, including statements regarding the timing of Biosplice’s anticipated regulatory submissions, including its intended submission to the EMA, the MHRA’s assessment of Biosplice’s marketing authorisation application for lorecivivint, the expected timing and outcome of that assessment, the review and potential approval of lorecivivint by the MHRA, the FDA or any other regulatory authority, 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, including the possibility that a regulatory authority may request additional information, may extend or suspend its review timetable, or may decline to grant approval, and other risks associated with drug development and commercialization. Statements regarding statutory review timetables reflect published regulatory guidance and are not assurances as to the timing of any regulatory decision. 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. ________________________ 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: ezstandalone.cmd.push(function () { ezstandalone.showAds(135); }); CONTACT: Corporate Contact: Phil Wilson, CFO Biosplice Therapeutics, Inc. phil.wilson@biosplice.com

Clinical ResultPhase 3Phase 2

25 Aug 2026

·allsci.com

CDK8 emerges as potential disease-modifying target in osteoarthritis

Inhibiting a transcriptional kinase already explored in oncology can suppress the pathological cellular transition associated with cartilage breakdown in osteoarthritis (OA), according to preclinical findings published in Bone Research. The study, led by Scott J. Roberts at the Royal Veterinary College (RVC) in London, UK, provides in vivo evidence that cyclin-dependent kinase 8 (CDK8) inhibition can modulate processes involved in endochondral ossification and OA, reducing cartilage pathology in a spontaneous mouse model while affecting cartilage, bone, and inflammatory pathways. OA affects hundreds of millions of people worldwide, yet no disease-modifying OA drug (DMOAD) has reached the market. As the paper's authors note, "despite OA being the commonest form of arthritis, there are no disease-modifying therapeutics and clinical development of single-target approaches, including IL-1β and ADAMTS5, has failed despite promising data from preclinical models." CDK8, a kinase subunit of the Mediator transcriptional complex, was elevated in chondrocytes from human OA cartilage (Mankin scores 5–10) compared with non-lesion tissue, and lentiviral overexpression of CDK8 in chondrocyte models recapitulated pro-degenerative transcriptional signatures — supporting a functional rather than merely correlative role. The central mechanism involves CDK8's phosphorylation of STAT1 at serine-727 and its regulation of downstream Wnt, TGF-β, BMP, and NF-κB pathways, all of which govern chondrocyte differentiation state. In healthy articular cartilage, chondrocytes maintain a stable, non-hypertrophic phenotype; in OA, they aberrantly transition toward hypertrophy — upregulating mineralization markers and degradative enzymes while losing matrix-producing capacity. CDK8 inhibition, the authors propose, acts as a transcriptional rheostat that stabilizes the non-hypertrophic state by suppressing this axis. The in vivo component used male STR/Ort mice, a spontaneous OA model, dosed orally with 5 mg/kg of the selective CDK8/19 inhibitor MSC2530818 (MSC-818; biochemical IC₅₀ = 2.5 nmol/L) three times per week for 12 weeks, beginning at 22 weeks of age. Treated animals (n = 12 limbs from 6 mice) showed reduced Osteoarthritis Research Society International (OARSI) histological scores compared with vehicle-treated controls (n = 10 limbs from 5 mice), indicating attenuated cartilage degradation. Complementary matrix integrity scoring and Masson's Trichrome staining supported preservation of collagen architecture. Micro-computed tomography analysis showed reduced growth plate bridge number and areal density, particularly in the lateral compartment. Treadmill-based gait analysis indicated functional differences in treated animals consistent with reduced joint pathology. No overt toxicity was observed over the 12-week dosing period, though the study was not designed for formal safety profiling. In vitro, the chondroprotective effects were validated across multiple structurally distinct CDK8 inhibitor series, reducing the likelihood that findings reflect off-target compound activity. Bulk RNA sequencing identified downregulation of NF-κB and JAK-STAT inflammatory pathways and upregulation of extracellular matrix organization programs. Seahorse metabolic profiling indicated that CDK8 inhibition shifted chondrocytes away from glycolysis-dominant metabolism toward preserved oxidative phosphorylation capacity — a metabolic profile associated with healthier chondrocyte function. Effects were directionally consistent across primary equine articular chondrocytes from six donors and in THP-1-derived macrophages, where CDK8 inhibition reduced phospho-STAT1 and pro-inflammatory cytokine expression. A parallel 2025 publication reported that CDK8 promotes OA pathology via an NF-κB/senescence-associated secretory phenotype (SASP) axis — a distinct mechanistic angle that independently corroborates CDK8's relevance as an OA target. No CDK8 inhibitor has entered clinical development for any musculoskeletal indication. In oncology, the most clinically advanced agent in this class is romaciclib (RVU120), developed by Poland-based Ryvu Therapeutics, which is currently in Phase II trials for relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome, including the RIVER-81 study (NCT06191263). Other molecules include Biocad's BCD-115 (Senexin B), a selective CDK8/19 inhibitor. SEL120-34A, the same compound as romaciclib, was among the CDK8 inhibitors screened in the paper's in vitro chondrocyte platform. MSC-818 itself has not entered clinical trials in any indication and remains a research-stage tool compound. Biosplice Therapeutics submitted an NDA to the FDA in January 2026 for lorecivivint, a CLK2/DYRK1A inhibitor that modulates Wnt signaling via alternative splicing and is administered by intra-articular injection — described at submission as the first DMOAD candidate ever filed for FDA approval, though no approval has been confirmed as of the current date. Sprifermin, a recombinant FGF18 developed by Merck KGaA in collaboration with Nordic Bioscience, completed Phase II with five-year cartilage thickness benefit in the FORWARD study; no confirmed active Phase III trial has been identified. The authors describe CDK8/19 inhibition as "a promising disease-modifying strategy for targeting whole-joint disease in OA," citing its simultaneous effects across cartilage, bone, and inflammatory cell types. The study was conducted by a consortium spanning the RVC, University College London, Middlesex University, the Institute of Cancer Research, and the University of Oxford, with human cartilage sections provided by Erasmus MC in Rotterdam. Authors Wells and Roberts disclosed a patent application (WO2023/237861) relating to CDK8/19 inhibitor development. Spot something wrong? Report an issue with this article

Phase 2Clinical ResultPhase 3NDA

22 Apr 2026

·allsci.com

4Moving Biotech’s 4P004 GLP-1 analog gains FDA Fast Track status for knee osteoarthritis

4Moving Biotech, a clinical-stage biotechnology company headquartered at the Pasteur Institute in Lille, France, announced receipt of US FDA Fast Track Designation for 4P004, a glucagon-like peptide-1 (GLP-1) analog engineered for intra-articular administration. The award focused on the molecule’s potential use as a third-line treatment of knee osteoarthritis in patients with synovitis. Fast Track Designation enables more frequent FDA interactions during development, including rolling review of data, and applies here to a program that has no prior expedited designation on record. The designation is specifically scoped to a treatment-refractory knee osteoarthritis subpopulation defined by the presence of synovitis, a narrower target than the broader disease category. 4P004 is formulated for direct injection into the knee joint rather than systemic administration. The company describes it as leveraging GLP-1’s analgesic, anti-inflammatory, anti-catabolic, and anabolic properties across joint tissues, with the intent of modifying disease progression rather than providing symptomatic relief alone. 4Moving Biotech was spun out of 4P-Pharma in mid-2020 and does not carry a stock exchange listing. The Phase I LASARE trial, results from which were disclosed in June 2024, enrolled 34 patients with knee osteoarthritis across three Belgian sites in a randomized, double-blind, placebo-controlled design. Single intra-articular injections of 4P004 were tested at doses from 0.3 mg to 3.0 mg. The trial met its primary safety objective, with expected adverse events in the 4P004 groups comparable to placebo. Pharmacokinetic data showed systemic liraglutide exposure below levels reported for subcutaneous administration of the approved formulation Victoza, which the company cited as supporting a 505(b)(2) regulatory pathway in the US. A pharmacologically active dose was identified from the ascending-dose cohorts. No specific pain endpoint scores, p-values, or quantitative PK parameters were disclosed in the public announcement; those figures were not available in any parallel public source at the time of writing. The ongoing Phase IIa INFLAM MOTION trial (CTIS2024-518916-38-00) is a multicenter, randomized, double-blind, placebo-controlled proof-of-concept study enrolling patients with knee synovitis and osteoarthritis across sites in the EU and North America. Topline results are expected in early 2027. The company states that US enrollment was enabled following an Investigational New Drug (IND) clearance in January 2025. No disease-modifying osteoarthritis drug (DMOAD) has received regulatory approval from the US FDA, EMA, or any other major agency. Approved pharmacological options for knee osteoarthritis — including non-steroidal anti-inflammatory drugs, duloxetine, and intra-articular corticosteroids or hyaluronic acid — address symptoms without altering structural disease progression. The subpopulation targeted by 4P004, patients with active synovitis who have failed multiple prior therapies, has no approved disease-modifying option. 4P004’s mechanistic distinction from prior DMOAD candidates lies in its use of the GLP-1 pathway at the joint level. Unlike sprifermin, which targets chondrocyte proliferation via FGF18, or lorecivivint, which inhibits CLK2 and DYRK1A to modulate Wnt signaling, 4P004 is positioned to act on inflammatory, catabolic, and anabolic pathways simultaneously through GLP-1 receptor engagement in joint tissue. The intra-articular route is shared with sprifermin and lorecivivint, and is intended to limit systemic exposure — a design rationale that the LASARE PK data were cited to support. The GLP-1 receptor biology underlying 4P004 is distinct from the systemic metabolic applications of GLP-1 agonists such as semaglutide or liraglutide. Whether GLP-1 receptor expression in synovial tissue and chondrocytes is sufficient to drive the anti-catabolic and anabolic effects the company describes has not been established in peer-reviewed clinical data from the 4P004 program to date. The INFLAM MOTION trial is designed to generate the translational evidence needed to address that question. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 1Fast TrackPhase 2Clinical ResultIND

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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05603754 (STRIDES, CTgov)	Phase 3	Osteoarthritis, Knee	499	Lorecivivint (Lorecivivint)	qxnjyfmqlx(tymcweugwt) = ioxsjepwws wjjmnuwvcz (ggioigmphq, 2.44) View more	-	01 Sep 2026
				Placebo (Vehicle)	qxnjyfmqlx(tymcweugwt) = bhqofuafbi wjjmnuwvcz (ggioigmphq, 2.45) View more
NCT04931667 (CTgov)	Phase 3	Osteoarthritis, Knee	72	Lorecivivint	hvtjlozour(htcitzqlgm) = bhetfcdjtk axncfmusyv (vstvrbtrjh, qaboffldiu - goktbholmo) View more	-	31 Mar 2026
NCT04520607 (OA-07, CTgov)	Phase 3	Osteoarthritis, Knee	276	Placebo+Lorecivivint (Placebo)	wilxlixrpv(ozwujmdbhz) = zlcsmvvljb scvvuznqmz (dbobroswef, 0.05) View more	-	24 Mar 2026
				Lorecivivint (Lorecivivint)	wilxlixrpv(ozwujmdbhz) = fcuudgrbwe scvvuznqmz (dbobroswef, 0.05) View more
NCT03706521 (CTgov)	Phase 2	Osteoarthritis, Knee	13	lorecivivint	rrngudirjz(cktqeywzeh) = vdkpctpvid uqbcfkbyyp (aurnffisek, weadrohver - zdrnqgzluh) View more	-	04 Mar 2026
NCT03928184 (STRIDES-Xray \| OA-07, CTgov)	Phase 3	Osteoarthritis, Knee	501	Lorecivivint (0.07 mg Lorecivivint)	bhhrhrorzj(gveukxgoye) = lvnddmazjm rswsdthnjm (ouodlqutom, 0.13) View more	-	13 Feb 2026
				Placebo (Vehicle)	bhhrhrorzj(gveukxgoye) = rbvimfxgpd rswsdthnjm (ouodlqutom, 0.13) View more
NCT04385303 (STRIDES-1 \| OA-10, CTgov)	Phase 3	Osteoarthritis, Knee	496	Placebo (Vehicle)	lkcfiynqcl(vjwvgkhuve) = vdblzyepdz ocplcartsg (rfzvusdenc, 0.14) View more	-	04 Feb 2026
				Lorecivivint (Lorecivivint)	lkcfiynqcl(vjwvgkhuve) = lrdykprzim ocplcartsg (rfzvusdenc, 0.14) View more
NCT03727022 (CTgov)	Phase 2	Osteoarthritis, Knee	101	Placebo (Vehicle)	vpqqysvnkv(xrvcaolpym) = mlozcivues oqtzhtydub (lwtdtqoqkd, 8.21) View more	-	12 Jan 2026
				SM04690 (0.07 mg SM04690)	vpqqysvnkv(xrvcaolpym) = azmkdfmxhn oqtzhtydub (lwtdtqoqkd, 10.00) View more
NCT04520607 (OA-07, ACR2025)	Phase 3	Osteoarthritis, Knee	276	Lorecivivint	yrzegysaty(amkxczqtvh) = cnzctayusq jpafjelxja (dwytrxzjaj ) View more	Positive	24 Oct 2025
				Placebo	yrzegysaty(amkxczqtvh) = sktqvqwids jpafjelxja (dwytrxzjaj ) View more
NCT04520607 (OA-07, ACR2025)	Phase 3	Osteoarthritis, Knee	501	Lorecivivint	onkgfutxvq(jceobwwnux): 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	lxmdetsgni(jcbgcpqezt) = kznwiklwih ygeujllgrn (laiveaesnh ) View more	Positive	10 Nov 2024
				Placebo	lxmdetsgni(jcbgcpqezt) = giknreuzdk ygeujllgrn (laiveaesnh ) View more

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