Scilex Holding Co (SCLX)
Scilex Holding Company is a biopharmaceutical enterprise that specializes in the development and market introduction of non-opioid therapies designed to alleviate both acute and chronic pain. Its primary marketed offering is ZTlido 1.8%, a topical prescription formulation of lidocaine specifically engineered to mitigate neuropathic discomfort associated with post-herpetic neuralgia, a condition characterized by persistent nerve pain following shingles. Beyond this, the company's development pipeline includes SP-102, a viscous gel corticosteroid for epidural administration, currently undergoing Phase III trials for lumbosacral radicular pain. Another candidate, SP-103, is progressing through Phase II trials for managing low back pain. Furthermore, SP-104, a novel, low-dose, delayed-release naltrexone hydrochloride formulation, has successfully concluded Phase I clinical testing for the treatment of fibromyalgia. Its corporate offices are situated in Palo Alto, California. Scilex Holding Company operates as a subsidiary of Sorrento Therapeutics, Inc.
Sector: Biological Products, (No Diagnostic Substances)
Industry: Drug Manufacturers - General
Scilex Holding Company
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Completed
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
SP-102, Placebo
Lumbosacral Radicular Pain
NCT03372161Enrollment401StartDec 2017Primary CompletionAug 2021CompletionJan 2022 - Phase 2Completed
Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain
SP-103, Placebo
Moderate to Severe Acute Lower Back Pain
NCT05096494Enrollment76StartApr 2022Primary CompletionMay 2023CompletionMay 2023 - Phase 1Completed
Pharmacokinetic Study of Lidocaine Patch 1.8% Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
Lidocaine patch 1.8%, Lidocaine 5% patch
Healthy
NCT04144192Enrollment58StartApr 2014Primary CompletionJul 2014CompletionJul 2014 - Phase 1Completed
Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
Lidocaine topical system 1.8%, Lidocaine patch 5%
Healthy
NCT04149938Enrollment54StartSep 2016Primary CompletionOct 2016CompletionOct 2016 - Phase 1Completed
Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% Under Conditions of Heat and Exercise
Lidocaine topical system 1.8%
Healthy
NCT04150536Enrollment12StartJan 2016Primary CompletionJan 2016CompletionJan 2016 - Phase 1Completed
Adhesion of Lidocaine Topical System 1.8%
Lidocaine topical system 1.8%
Healthy
NCT04312750Enrollment54StartDec 2015Primary CompletionDec 2015CompletionDec 2015 - Phase 1Completed
Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Generic Lidocaine Patch 5% in Healthy, Adult, Human Subjects
lidocaine topical system 1.8%, lidocaine patch 5%
Healthy
NCT04319926Enrollment24StartSep 2018Primary CompletionSep 2018CompletionSep 2018 - Phase 1Completed
Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Lidocaine Patch 5% and Lidocaine Medicated Plaster 5% in Healthy, Adult, Human Subjects
Lidocaine patch 1.8%, Lidocaine patch 5%
Healthy
NCT04320173Enrollment47StartFeb 2017Primary CompletionMar 2017CompletionMar 2017 - Phase 1Completed
Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% With Water Exposure
Lidocaine topical system 1.8%
Healthy
NCT04784728Enrollment24StartAug 2019Primary CompletionAug 2019CompletionAug 2019 - Phase 1Completed
Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects
SP-103, ZTlido
Healthy
NCT04819581Enrollment15StartAug 2019Primary CompletionAug 2019CompletionAug 2019 - Phase 1Completed
Study to Evaluate the Safety of SP-104
SP-104, Naltrexone immediate release oral capsules
Healthy Volunteers
NCT04958876Enrollment52StartOct 2021Primary CompletionDec 2021CompletionDec 2021 - Phase 1Completed
Pharmacokinetics of SP-104
SP-104, Naltrexone Hydrochloride 50Mg Oral Tablet
Healthy
NCT05002946Enrollment18StartJan 2022Primary CompletionApr 2022CompletionApr 2022 - Phase 1Completed
Clinical Adhesion Study Between ZTlido 1.8% and Three Over-the-counter External Analgesic Lidocaine-containing Patches
ZTlido (Lidocaine Topical System) 1.8%, Salonpas (Lidocaine Patch 4%)
Healthy
NCT05106400Enrollment24StartJul 2021Primary CompletionJul 2021CompletionJul 2021 - Not applicableUnknown status
Enhanced Safety Laser Hair Removal System
Peterio
Hirsutism, Hypertrichosis
NCT00441948Enrollment10StartMay 2007Primary Completion-CompletionApr 2008 - Not applicableUnknown status
Enhanced Safety Aesthetic Laser System
Peterio
Hirsutism, Hypertrichosis +2
NCT00495443Enrollment25StartSep 2007Primary Completion-CompletionSep 2008est.
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Completed | SP-102, Placebo | NCT03372161 |
| Phase 2 | Completed | SP-103, Placebo | NCT05096494 |
| Phase 1 | Completed | Lidocaine patch 1.8%, Lidocaine 5% patch | NCT04144192 |
| Phase 1 | Completed | Lidocaine topical system 1.8%, Lidocaine patch 5% | NCT04149938 |
| Phase 1 | Completed | Lidocaine topical system 1.8% | NCT04150536 |
| Phase 1 | Completed | Lidocaine topical system 1.8% | NCT04312750 |
| Phase 1 | Completed | lidocaine topical system 1.8%, lidocaine patch 5% | NCT04319926 |
| Phase 1 | Completed | Lidocaine patch 1.8%, Lidocaine patch 5% | NCT04320173 |
| Phase 1 | Completed | Lidocaine topical system 1.8% | NCT04784728 |
| Phase 1 | Completed | SP-103, ZTlido | NCT04819581 |
| Phase 1 | Completed | SP-104, Naltrexone immediate release oral capsules | NCT04958876 |
| Phase 1 | Completed | SP-104, Naltrexone Hydrochloride 50Mg Oral Tablet | NCT05002946 |
| Phase 1 | Completed | ZTlido (Lidocaine Topical System) 1.8%, Salonpas (Lidocaine Patch 4%) | NCT05106400 |
| Not applicable | Unknown status | Peterio | NCT00441948 |
| Not applicable | Unknown status | Peterio | NCT00495443 |