Lorecivivint

Generic Name: Lorecivivint

Drug Type: Small Molecule

Chemical Formula: C_₂₉H_₂₄FN_₇O

CAS Number: 1467093-03-3

Unique Ingredient Identifier: 42EK42WHI5

Overview

Lorecivivint is under investigation in clinical trial NCT03246399 (A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease).

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (STRIDES)	2022/11/03	NCT05603754	Phase 3	Completed	Biosplice Therapeutics, Inc.
3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the Knee	2021/06/18	NCT04931667	Phase 3	Terminated	Biosplice Therapeutics, Inc.
Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers	2020/10/22	NCT04598542	Phase 1	Completed	Biosplice Therapeutics, Inc.
A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee	2020/08/20	NCT04520607	Phase 3	Completed	Biosplice Therapeutics, Inc.
A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis	2020/05/12	NCT04385303	Phase 3	Completed	Biosplice Therapeutics, Inc.
A Study Utilizing Patient-Reported and Radiographic Outcomes and Evaluating the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis	2019/04/26	NCT03928184	Phase 3	Completed	Biosplice Therapeutics, Inc.
A Study Evaluating the Safety, Tolerability and Efficacy of Two Injections of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis	2018/11/01	NCT03727022	Phase 2	Completed	Biosplice Therapeutics, Inc.
A Study Utilizing Imaging Techniques and Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis	2018/10/16	NCT03706521	Phase 2	Terminated	Biosplice Therapeutics, Inc.
A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease	2017/08/11	NCT03246399	Phase 1	Terminated	Biosplice Therapeutics, Inc.
A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis	2017/04/21	NCT03122860	Phase 2	Completed	Biosplice Therapeutics, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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