SRP-001 / South Rampart Pharma - LARVOL DELTA

Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA) (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: South Rampart Pharma, LLC | Trial completion date: Feb 2024 ➔ Mar 2026 | Trial primary completion date: Oct 2023 ➔ Dec 2025

Trial completion date • Trial primary completion date • Pain

South Rampart Pharma Expands Global Patent Portfolio with EU Approval for FDA Fast-Tracked SRP-001 for Pain (PRNewswire) - "South Rampart Pharma, Inc...announced today the issuance of European Patent No. 3672938 by the European Patent Office (EPO) effective November 1, 2023. This patent will apply to all Unified Patent Court-participating and non-participating European Unitary member states....This includes the Company's lead clinical candidate, SRP-001, which the U.S. FDA granted Fast Track designation for acute pain on October 9, 2023, and is ending Phase 1 clinical trials (NCT05484414). This patent, excluding possible patent term extensions, is expected to provide South Rampart with market exclusivity in the EPO member states until 2038, aligning with the U.S. Patent No. 11,458,142, issued on October 4, 2022."

Fast track designation • Patent • Trial status • CNS Disorders • Pain

South Rampart Pharma Successfully Completes Phase 1 Study and Expands Phase 2 Plans to Include Neuropathic and Acute Pain Trials (PRNewswire) - P1 | N=56 | NCT05484414 | Sponsor: South Rampart Pharma, LLC | "South Rampart Pharma, Inc...announced today that it has successfully completed a Phase 1 trial (NCT05484414)....Safety Profile: The study reported no serious adverse events (SAEs). Clinical laboratory evaluations indicated no abnormalities, including clinical chemistry, hematology, urinalysis, vital signs, ECG, and physical examinations. Normal liver and kidney function tests support the Company's earlier findings. Pharmacokinetics: SRP-001 demonstrated a half-life of 10.1 hours, significantly longer than existing pain medications. The PK profile included a detailed analysis of Tmax, Cmax, AUC(0-tau), AUC(0-last), AUC(0-inf), and T1/2, providing a comprehensive understanding of the drug's behavior in the body."

P1 data • Trial completion • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA) (clinicaltrials.gov) - P1 | N=56 | Active, not recruiting | Sponsor: South Rampart Pharma, LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2023 ➔ Feb 2024

Enrollment closed • Trial completion date • Pain

Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA) (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: South Rampart Pharma, LLC | Trial completion date: Dec 2022 ➔ Mar 2023 | Initiation date: Nov 2021 ➔ Jan 2023 | Trial primary completion date: Dec 2022 ➔ Mar 2023

Trial completion date • Trial initiation date • Trial primary completion date • Pain

Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA) (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: South Rampart Pharma, LLC

New P1 trial • Pain