Semnur Pharmaceuticals, Inc.
Semnurpharma is a biopharmaceutical company focused on the clinical and commercial development of novel non-opioid products for pain management. Their lead program, SP-102 (SEMDEXA™), is a non-opioid injectable corticosteroid gel formulation for patients with moderate to severe chronic radicular pain/sciatica. The company aims to address the unmet medical needs in pain management, especially in the context of the opioid epidemic, by providing effective non-opioid therapies.
Industries
Nr. of Employees
small (1-50)
Semnur Pharmaceuticals, Inc.
960 San Antonio Road, Palo Alto, CA, 94303
Patents
Products
Viscous dexamethasone gel injectable for epidural administration (lead clinical candidate)
A viscous corticosteroid gel formulation developed for epidural injection to treat lumbosacral radicular pain, designed to increase local residency time and to avoid particulates, preservatives, surfactants and solvents in the drug product.
Viscous dexamethasone gel injectable for epidural administration (lead clinical candidate)
A viscous corticosteroid gel formulation developed for epidural injection to treat lumbosacral radicular pain, designed to increase local residency time and to avoid particulates, preservatives, surfactants and solvents in the drug product.
Services
End-to-end clinical development services including study design, site coordination, trial conduct and data dissemination for therapies targeting radicular and chronic pain.
Regulatory engagement, planning and submission activities including Fast Track interactions, formal FDA meetings and preparation for NDA filing.
Market analysis, peak sales modeling and commercialization planning for non-opioid pain management products in collaboration with third-party market research firms.
End-to-end clinical development services including study design, site coordination, trial conduct and data dissemination for therapies targeting radicular and chronic pain.
Regulatory engagement, planning and submission activities including Fast Track interactions, formal FDA meetings and preparation for NDA filing.
Market analysis, peak sales modeling and commercialization planning for non-opioid pain management products in collaboration with third-party market research firms.
Expertise Areas
- Clinical trial management (Phase 1–3)
- Formulation development for injectable sustained‑residence therapies
- Pharmacokinetics and clinical pharmacology
- Regulatory strategy and FDA engagement
Key Technologies
- Viscous corticosteroid gel formulation
- Epidural injectable delivery
- Sustained‑residence local delivery methods
- PK/PD analysis and biomarker monitoring (cortisol, WBC, glucose)
News & Updates
On November 6th, 2024, Semnur Pharmaceuticals announced the filing of a registration statement on Form S-4 by Denali Capital Acquisition Corp. with the SEC, relating to a proposed business combination between Semnur and Denali.
On November 6th, 2024, Semnur announced highly significant positive top-line results from its Phase 3 pivotal trial for SP-102 (SEMDEXA™) for sciatica pain management.
On January 7, 2018, Semnur announced the start of a pivotal Phase 3 clinical trial in the U.S. for its lead product SP-102 in patients with lumbar radicular pain/sciatica, which was granted Fast Track designation by the FDA.
A study published on May 5, 2022, reports results from a Phase 3 trial of SP-102, a novel dexamethasone injectable formulation, showing its efficacy in treating lumbar radiculopathy (sciatica).
Semnur Pharmaceuticals was recognized as a TiE50 Award winner in 2014, highlighting it as one of the world's most enterprising technology startups.
On November 6th, 2024, Semnur Pharmaceuticals announced the filing of a registration statement on Form S-4 by Denali Capital Acquisition Corp. with the SEC, relating to a proposed business combination between Semnur and Denali.
On November 6th, 2024, Semnur announced highly significant positive top-line results from its Phase 3 pivotal trial for SP-102 (SEMDEXA™) for sciatica pain management.
On January 7, 2018, Semnur announced the start of a pivotal Phase 3 clinical trial in the U.S. for its lead product SP-102 in patients with lumbar radicular pain/sciatica, which was granted Fast Track designation by the FDA.
A study published on May 5, 2022, reports results from a Phase 3 trial of SP-102, a novel dexamethasone injectable formulation, showing its efficacy in treating lumbar radiculopathy (sciatica).
Semnur Pharmaceuticals was recognized as a TiE50 Award winner in 2014, highlighting it as one of the world's most enterprising technology startups.