Trichomylin (fixed-dose cannabinoid formulation) / ZYUS - LARVOL DELTA

UTOPIA-1: Unique Treatment of Oncology Pain in Advanced Cancer (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: ZYUS Life Sciences Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pain

UTOPIA-1: Unique Treatment of Oncology Pain in Advanced Cancer (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: ZYUS Life Sciences Inc. | Trial completion date: Mar 2025 ➔ Nov 2025 | Initiation date: Nov 2024 ➔ Apr 2025 | Trial primary completion date: Mar 2025 ➔ Nov 2025

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

UTOPIA-1: Unique Treatment of Oncology Pain in Advanced Cancer (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: ZYUS Life Sciences Inc.

Metastases • New P2 trial • Oncology • Pain

HOPE: Trichomylin® Safety, Tolerability & Pharmacokinetics in Healthy Adults and First in Human Osteoarthritis Pain Evaluation (clinicaltrials.gov) - P1 | N=41 | Completed | Sponsor: ZYUS Life Sciences Inc. | Recruiting ➔ Completed

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

ZYUS Life Sciences Corporation Announces Positive Phase I Clinical Trial Results for Trichomylin Softgels (Yahoo Finance) - "Completion of Phase 1 and supportive preclinical data will assist in ongoing phase 2 clinical development of ZYUS’ lead drug product candidate...ZYUS Life Sciences Corporation...is pleased to announce receipt of the final clinical study report and positive results respecting its Phase 1, first-in-human ('FIH') Clinical Trial for its lead drug product candidate, Trichomylin® softgels."

P1 data • Trial completion • CNS Disorders • Osteoarthritis • Pain

ZYUS Life Sciences Receives Notice of Allowance for Canadian Patent Application Covering Pain Management (Businesswire) - "ZYUS Life Sciences...announced today that it has received a Notice of Allowance from the Canadian Intellectual Property Office (CIPO) for Canadian Patent Application No. 3,102,473, entitled FORMULATION FOR PAIN MANAGEMENT. The patent covers novel fixed-dose cannabinoid formulations for pain management, including pain due to arthritis, neuropathic pain...'we are working to demonstrate Trichomylin’s potential through clinical applications to address patient needs and improve quality of life.'"

Patent • CNS Disorders • Neuralgia • Osteoarthritis • Pain

HOPE: Trichomylin® Safety, Tolerability, and Pharmacokinetics in Healthy Adults and First in Human Osteoarthritis Pain Evaluation (clinicaltrials.gov) - P1; N=56; Recruiting; Sponsor: ZYUS Life Sciences Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

HOPE: Trichomylin® Safety, Tolerability, and Pharmacokinetics in Healthy Adults and First in Human Osteoarthritis Pain Evaluation (clinicaltrials.gov) - P1; N=56; Not yet recruiting; Sponsor: ZYUS Life Sciences Inc.

Clinical • New P1 trial • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

ZYUS Launches HOPE (Human Osteoarthritis Pain Evaluation) Phase 1 First in Human Clinical Trials (Businesswire) - "ZYUS...announced today that it will be launching a first-in-human (FIH) clinical trial on the safety, tolerability and efficacy of its lead drug product candidate, Trichomylin...ZYUS also submitted a request for a pre-Investigational New Drug ('Pre-IND') meeting with the U.S. Food and Drug Administration (FDA)...The 505(b)(1) drug development regulatory pathway would provide ZYUS with a rigorous framework within which it could conduct human studies on the safety and efficacy of Trichomylin®...The clinical research will be split into two phases: Phase 1a will evaluate drug safety and tolerability in healthy participants starting April 2021, with initial results expected by fall 2021. Phase 1b will evaluate the efficacy of Trichomylin® for pain management in a limited number of patients with osteoarthritis, with results expected late 2021."

FDA event • New P1 trial • P1 data • Osteoarthritis • Pain