COMPANY

Biosplice Therapeutics

HQ: San Diego, CA source · biosplice.com ↗ · West Coast

Keywords: small molecule Androgenetic Alopecia Knee Osteoarthritis Tendinopathy Colorectal Cancer Osteoarthritis Gastric Cancer Hepatic Cancer Pancreatic Cancer Osteoarthritis of the Knee Castration-resistant Prostate Cancer Non-small Cell Lung Cancer Drug-Drug Interaction Degenerative Disc Disease Idiopathic Pulmonary Fibrosis Moderate to Severe Osteoarthritis SM04755 Lorecivivint SM04690 SM08502 SM04646

Location: San Diego, CA · source · Oct 13, 2026

Profile checked Oct 10, 2026

22Trials (company is sponsor)

Timeline

Nov 18, 2022 Trial start Phase 3: Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis (STRIDES) source ↗
Nov 3, 2021 Trial start Phase 1: A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors source ↗
Jul 15, 2021 Trial start Phase 3: 3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Knee Osteoarthritis source ↗
Oct 13, 2020 Trial start Phase 1: Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers source ↗
Aug 25, 2020 Trial start Phase 3: A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee source ↗
May 26, 2020 Trial start Phase 3: Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1) source ↗
May 17, 2019 Trial start Phase 3: Patient-Reported and Radiographic Outcomes in Evaluating Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis source ↗
Mar 11, 2019 Trial start Phase 2: MRI Study to Evaluate the Safety and Efficacy of SM04690 for Knee Osteoarthritis source ↗
Nov 28, 2018 Trial start Phase 2: Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis source ↗
Nov 1, 2018 Trial start Phase 2/Phase 3: A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia source ↗
Nov 6, 2017 Trial start Phase 1: A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors source ↗
Sep 11, 2017 Trial start Phase 1: A Repeat Insult Patch Test (RIPT) Study Evaluating the Sensitization Potential of Topical SM04755 Solution in Healthy Volunteers source ↗
Jul 26, 2017 Trial start Phase 1: A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease source ↗
Apr 24, 2017 Trial start Phase 2: A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis source ↗
Nov 3, 2016 Trial start Phase 1: A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects source ↗
Sep 19, 2016 Trial start —: An Observational Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symp source ↗
Sep 9, 2015 Trial start Phase 2: A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects source ↗
2015-08 Trial start Phase 2: A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing source ↗
2014-11 Trial start Phase 2: A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA) source ↗
Jun 19, 2014 Trial start Phase 1: Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer source ↗
2014-03 Trial start 1: Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA) source ↗
1900-01 Trial start Phase 2: A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of SM04646 Inhalation Solution in Subjects With Idiopathic Pulmonary Fibrosis (IPF) source ↗

Clinical trials (lead sponsor) 22

Record	Title	Phase	Status	Start	Primary completion
NCT03502434	A Repeat Insult Patch Test (RIPT) Study Evaluating the Sensitization Potential of Topical SM04755 Solution in Healthy Volunteers	Phase 1	Completed	Sep 11, 2017	Nov 17, 2017 (actual)
NCT02503137	A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing	Phase 2	Completed	2015-08	2016-04 (actual)
NCT02191761	Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer	Phase 1	Completed	Jun 19, 2014	May 20, 2015 (actual)
NCT03742518	A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia	Phase 2/Phase 3	Completed	Nov 1, 2018	Dec 31, 2020 (actual)
NCT02275351	A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)	Phase 2	Completed	2014-11	2015-11 (actual)
NCT05603754	Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis (STRIDES)	Phase 3	Completed	Nov 18, 2022	Feb 20, 2024 (actual)
NCT04931667	3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Knee Osteoarthritis	Phase 3	Terminated	Jul 15, 2021	Dec 13, 2021 (actual)
NCT04520607	A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee	Phase 3	Terminated	Aug 25, 2020	Jun 30, 2023 (actual)
NCT03706521	MRI Study to Evaluate the Safety and Efficacy of SM04690 for Knee Osteoarthritis	Phase 2	Terminated	Mar 11, 2019	Jul 22, 2020 (actual)
NCT03928184	Patient-Reported and Radiographic Outcomes in Evaluating Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis	Phase 3	Completed	May 17, 2019	Aug 20, 2021 (actual)
NCT04385303	Patient-Reported Outcomes in Evaluating Lorecivivint (SM04690) for Moderate to Severe Knee Osteoarthritis (STRIDES-1)	Phase 3	Completed	May 26, 2020	Sep 8, 2021 (actual)
NCT03727022	Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis	Phase 2	Completed	Nov 28, 2018	Sep 18, 2020 (actual)
NCT03355066	A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors	Phase 1	Terminated	Nov 6, 2017	Nov 14, 2022 (actual)
NCT05084859	A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors	Phase 1	Terminated	Nov 3, 2021	Oct 20, 2022 (actual)
NCT03122860	A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis	Phase 2	Completed	Apr 24, 2017	Apr 30, 2018 (actual)
NCT02536833	A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects	Phase 2	Completed	Sep 9, 2015	Apr 20, 2017 (actual)
NCT04598542	Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers	Phase 1	Completed	Oct 13, 2020	Dec 22, 2020 (actual)
NCT02951026	An Observational Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis	Not listed	Completed	Sep 19, 2016	Oct 31, 2019 (actual)
NCT03246399	A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease	Phase 1	Terminated	Jul 26, 2017	Nov 14, 2018 (actual)
NCT03591926	A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of SM04646 Inhalation Solution in Subjects With Idiopathic Pulmonary Fibrosis (IPF)	Phase 2	Withdrawn	1900-01	1900-01 (estimated)
NCT03229291	A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects	Phase 1	Completed	Nov 3, 2016	Jun 11, 2017 (actual)
NCT02095548	Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)	1	Completed	2014-03	2015-09 (actual)