naproxen/pregabalin (XG005-03) / Xgene Pharma - LARVOL DELTA

The efficacy and safety of XG005, a novel non-opioid chemical entity concurrently inhibiting both nociceptive and neuropathic signals, in managing post-operative pain: a randomized, placebo-controlled phase 2b trial (PAINWeek 2025) - P2/3 | "XG005 is a single molecule conjugating naproxen and pregabalin, which is not active in gastrointestinal tract and thus minimizes naproxen side effects compared with administering naproxen directly...Qualified subjects were randomized (1:1:1) to receive either 1250 mg or 750 mg of XG005 tablets, or placebo...Tramadol consumption in the placebo group was 4.1- or 3.0-fold more than in the 1250 mg or 750 mg groups over 72 hours, and those were 3- or 2.5-fold in acetaminophen consumption...In comparison with other analgesics to treat acute pain using the same bunionectomy model with the same efficacy endpoint (SPI48) or Summed Pain Intensity Difference at 48 hours (SPID48), the pooled mean effect sizes are: 0.59 with various NSAIDs, 0.52 with various opioids combination with either acetaminophen or NSAIDs, 0.88 with tapentadol (an opioid) and 0.36 with a Nav1.8 antagonist... This trial randomized 450 participants (median age, 48 years; 80% female) with comparable..."

Clinical • P2b data • Addiction (Opioid and Alcohol) • CNS Disorders • Neuralgia • Pain • Psychiatry • Sleep Disorder • NAV1

Changyu Pharmaceutical completes C round of financing of 40 million US dollars [Google translation] (Eastmoney.com) - "According to reports from the investment community, Changyu Pharmaceutical (Shanghai) Co., Ltd. completed the C round of financing of 40 million US dollars and obtained over-raising....This round of financing will continue to develop original dual-target molecules based on Changyu Pharmaceutical’s proprietary coupled drug technology platform, including the first product XG005, which will be launched in the United States and China, respectively, in phase III and phase II acute and chronic pain (including tumor pain, Bone and joint pain) clinical trials..."

Financing • New P2 trial • New P3 trial • CNS Disorders • Pain

Phase 1 XG005-03 Topical Study (clinicaltrials.gov) - P1; N=36; Completed; Sponsor: Xgene Pharmaceutical Pty Ltd; Recruiting ➔ Completed; Trial primary completion date: Aug 2020 ➔ Jan 2021

Clinical • Trial completion • Trial primary completion date • Pain

Phase 1 XG005-03 Topical Study (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Xgene Pharmaceutical Pty Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open