resiniferatoxin (MCP-101) / Sorrento - LARVOL DELTA

Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: National Institute of Dental and Craniofacial Research (NIDCR) | Trial completion date: Feb 2025 ➔ Feb 2026 | Trial primary completion date: Feb 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Oncology • Pain • Palliative care

Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer (clinicaltrials.gov) - P2 | N=120 | Suspended | Sponsor: Sorrento Therapeutics, Inc. | Trial completion date: Dec 2024 ➔ Dec 2027 | Trial primary completion date: Jun 2024 ➔ Jun 2027

Metastases • Trial completion date • Trial primary completion date • Oncology • Pain

Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: National Institute of Dental and Craniofacial Research (NIDCR) | Trial completion date: Feb 2024 ➔ Feb 2025 | Trial primary completion date: Feb 2024 ➔ Feb 2025

Metastases • Trial completion date • Trial primary completion date • Oncology • Pain • Palliative care

Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: National Institute of Dental and Craniofacial Research (NIDCR) | Trial completion date: Aug 2023 ➔ Feb 2024 | Trial primary completion date: Aug 2023 ➔ Feb 2024

Metastases • Trial completion date • Trial primary completion date • Oncology • Pain • Palliative care

Sorrento Therapeutics Announces Positive Phase 2a Clinical Trial Results for Resiniferatoxin (RTX) for the Treatment of Knee Pain in Moderate to Severe Osteoarthritis of the Knee (OAK) Patients (GlobeNewswire) - P2a | N=124 | NCT04885972 | Sponsor: Sorrento Therapeutics, Inc. | "Sorrento Therapeutics, Inc...announced today positive Phase 2a top-line clinical trial results for the RTX program....Generally, treatment was well-tolerated, with the most common noted AE being pain following topical capsaicin 0.1% given to all patients for blinding purposes and study drug administration in the knee (across all dose groups)....The RTX 20mcg dose group performed best among all dose groups, including placebo (lidocaine only) and approved intra-articular corticosteroid (Zilretta) on short-term and prolonged pain relief measures (SPID, KOOS, WOMAC)....A higher proportion of patients responded to treatment with RTX 20mcg than any other treatment group, including Zilretta. Reduction in pain was also more pronounced with RTX 20mcg than with any other treatment group, including placebo and active control."

P2a data • CNS Disorders • Osteoarthritis • Pain

Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer (clinicaltrials.gov) - P2 | N=120 | Suspended | Sponsor: Sorrento Therapeutics, Inc. | Trial completion date: Dec 2023 ➔ Dec 2024 | Recruiting ➔ Suspended | Trial primary completion date: Jun 2023 ➔ Jun 2024

Metastases • Trial completion date • Trial primary completion date • Trial suspension • Oncology • Pain

Safety and efficacy of intravesical instillation of resiniferatoxin in healthy cats: A preliminary study. (PubMed, Front Vet Sci) - "C-fiber ablation was observed in the urinary bladder tissue at all doses, as shown by an apparent reduction of both CGRP and SP immunoreactive axons. A dose of 25 μg (1 μg/mL) of RTX instilled in the urinary bladder of healthy cats appeared to decrease the density of SP and CGRP nerve axons innervating bladder and induced moderate changes in the bladder tissue."

Journal • Interstitial Cystitis • Pain

Study to Evaluate Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis (clinicaltrials.gov) - P2 | N=124 | Active, not recruiting | Sponsor: Sorrento Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Study to Evaluate Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis (clinicaltrials.gov) - P2 | N=112 | Recruiting | Sponsor: Sorrento Therapeutics, Inc. | Trial primary completion date: Aug 2022 ➔ Aug 2023

Trial primary completion date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Sorrento Therapeutics Completes Enrollment of Phase 2 Clinical Trial of Resiniferatoxin (RTX) for Treatment of Knee Pain in Moderate to Severe Osteoarthritis of the Knee (OAK) Patients (GlobeNewswire) - "Sorrento Therapeutics, Inc...announced today that the company has completed enrollment of its latest Phase 2 clinical study of RTX for treating moderate-to-severe osteoarthritis of the knee pain (OAK)....The RTX clinical development program in OAK pain continues to deliver as planned, with an end of phase 2 meeting with the FDA and concurrent phase 3 clinical trials planned in larger patient populations in the first half of 2023."

Enrollment closed • FDA event • New P3 trial • CNS Disorders • Osteoarthritis • Pain

Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Sorrento Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pain

Study to Evaluate Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis (clinicaltrials.gov) - P2 | N=112 | Recruiting | Sponsor: Sorrento Therapeutics, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2023 ➔ Nov 2023

Enrollment open • Trial completion date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: National Institute of Dental and Craniofacial Research (NIDCR) | Trial primary completion date: Dec 2022 ➔ Aug 2023

Trial primary completion date • Oncology • Pain • Palliative care

Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Sorrento Therapeutics, Inc. | Trial completion date: Dec 2022 ➔ Dec 2023 | Initiation date: Dec 2021 ➔ Jun 2022 | Trial primary completion date: Dec 2022 ➔ Jun 2023

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

Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: National Institute of Dental and Craniofacial Research (NIDCR) | Trial completion date: Dec 2022 ➔ Aug 2023

Trial completion date • Oncology • Pain • Palliative care

Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer (clinicaltrials.gov) - P1; N=45; Recruiting; Sponsor: National Institute of Dental and Craniofacial Research (NIDCR); Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Oncology • Pain • Palliative care

Sorrento Begins Enrollment in Phase 2 Trial of Resiniferatoxin (RTX) for the Treatment of Pain Due to Knee Osteoarthritis (OA) (GlobeNewswire) - "Sorrento Therapeutics...today announced that the Phase 2 clinical study of RTX for treating knee pain from osteoarthritis (OA) has begun enrollment. This study is a multi-center, double blind, placebo- and active-controlled study to assess the safety and efficacy of several dose levels of RTX to manage pain in patients associated with moderate-to-severe OA of the knee..."

Enrollment open • CNS Disorders • Osteoarthritis • Pain

Phase 3 Study to Assess Resiniferatoxin vs Standard of Care for the Treatment of Intractable Cancer Pain (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: Sorrento Therapeutics, Inc.; N=126 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Oncology • Pain

Study to Evaluate Resiniferatoxin in Patients With Knee Osteoarthritis Whose Total Knee Replacement Surgery is Delayed (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: Sorrento Therapeutics, Inc.; Not yet recruiting ➔ Withdrawn; N=152 ➔ 0

Clinical • Enrollment change • Trial withdrawal • Immunology • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Osteoarthritis • Pain • Rheumatology

A Phase 3 Study to Evaluate the Efficacy and Safety of Resiniferatoxin for Pain Due to Osteoarthritis of the Knee (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: Sorrento Therapeutics, Inc.; N=390 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer (clinicaltrials.gov) - P2; N=120; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

Clinical • New P2 trial • Oncology • Pain

Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer (clinicaltrials.gov) - P1; N=45; Recruiting; Sponsor: National Institute of Dental and Craniofacial Research (NIDCR); Trial primary completion date: Aug 2021 ➔ Dec 2021

Trial primary completion date • Oncology • Pain • Palliative care

FDA Clears Sorrento Phase 2 Trial Of Non-Opioid Product Candidate Resiniferatoxin (RTX) For Treatment of the Knee Pain in Osteoarthritis (OA) Patients (GlobeNewswire) - "Sorrento Therapeutics...announced today that the company has received FDA clearance to proceed with a Phase 2 clinical study of RTX for treating moderate-to-severe osteoarthritis of the knee pain (OAK)....The phase 2 trial, a multi-center, double blind, placebo- and active-controlled study, will assess the efficacy and safety of several dose groups of RTX to manage pain in patients with moderate-to-severe osteoarthritis of the knee pain (OAK)."

New P2 trial • CNS Disorders • Osteoarthritis • Pain

Study to Evaluate Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis (clinicaltrials.gov) - P2; N=112; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

Clinical • New P2 trial • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Study of Resiniferatoxin for Knee Pain in Moderate to Severe Osteoarthritis (clinicaltrials.gov) - P1b; N=94; Completed; Sponsor: Sorrento Therapeutics, Inc.; Active, not recruiting ➔ Completed

Trial completion • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology