Tris Pharma Launches Adneuris Therapeutics to Advance First-in-Class Dual-NMR Agonist Cebranopadol for Moderate-to-Severe Acute Pain
Key Insights
Tris Pharma has launched Adneuris Therapeutics (search), a wholly owned subsidiary dedicated to developing and commercializing cebranopadol, an investigational first-in-class dual NOP/MOP receptor (search) agonist for pain management.
Cebranopadol has completed two pivotal Phase 3 trials, ALLEVIATE-1 and ALLEVIATE-2, demonstrating significant pain reduction versus placebo over 48 hours and reduced opioid rescue medication use.
The dual-NMR agonist mechanism is designed to provide robust analgesia with a differentiated safety profile, potentially reducing risks of dependence, misuse, and addiction compared to conventional opioids like oxycodone.
Tris Pharma announced on July 9, 2026, the launch of Adneuris Therapeutics (search), a wholly owned subsidiary built to advance a bold new vision for pain medicine through the development and future commercialization of cebranopadol, its lead investigational therapy. The launch marks the next phase of Tris Pharma's growth strategy, with Adneuris anticipating the submission of a New Drug Application (NDA) for cebranopadol as a treatment for moderate-to-severe acute pain (search).
"For more than two decades, Tris Pharma has built its reputation by challenging convention and advancing medicines that address significant unmet needs," said Jim Potenziano, Ph.D., Chief Science and Development Officer of Tris Pharma. "The launch of Adneuris represents the next evolution of that commitment. We created Adneuris with a singular focus: to advance innovative science that has the potential to redefine pain management while putting patients and healthcare providers at the center of everything we do."
A Differentiated Mechanism of Action
Adneuris is built around a patient-first philosophy and a belief that effective pain management requires new approaches, not incremental improvements. Rather than relying solely on traditional opioid pathways, cebranopadol is designed to modulate pain through both the nociceptin/orphanin FQ peptide (NOP) and µ-opioid peptide (MOP) receptors, representing a differentiated scientific approach intended to balance strong analgesia with an improved safety profile. These receptors are partially homologous to each other and play both complementary and distinct roles in modulating pain biology pathways.
Cebranopadol has been studied in over 33 clinical trials with more than 2,400 participants enrolled across its studies. The clinical program has demonstrated positive results in acute pain, chronic pain, and diabetic neuropathic pain (search) with a favorable safety profile. The FDA granted Fast Track Designation to cebranopadol for chronic low back pain (search), and if approved, it has the potential to become the first dual-NMR agonist to provide robust pain relief with a reduced risk of dependence, misuse, addiction, or overdose compared to selective MOP agonists such as oxycodone.
Pivotal Phase 3 Results
Cebranopadol was evaluated in two pivotal Phase 3 trials: ALLEVIATE-1, conducted following abdominoplasty surgery, and ALLEVIATE-2, conducted following bunionectomy surgery. These studies assessed the efficacy and safety of cebranopadol in moderate-to-severe pain following soft- and hard-tissue surgical procedures.
In both studies, cebranopadol demonstrated a significant reduction in pain compared with placebo over 48 hours, reduced use of opioid rescue medication compared with placebo, and sustained pain control as shown by a longer time to first rescue dose. Together, these results support cebranopadol's potential to deliver efficacy comparable to standard-of-care therapies, with a differentiated safety profile designed to reduce the risk of side effects associated with conventional opioid treatments.
Addressing the Innovation Gap in Pain Management
"The innovation gap in pain has left patients and physicians with limited choices for too long — a gap Adneuris aims to address," said Ketan Mehta, Founder and Chief Executive Officer of Tris Pharma. "Millions of Americans continue to live with inadequately treated pain, while the lasting effects of the opioid epidemic have left patients and healthcare providers navigating increasingly difficult treatment decisions. Adneuris aims to meet that need by advancing cebranopadol, which has the potential to provide meaningful pain relief through a fundamentally new approach."
Beyond acute pain, cebranopadol's novel mechanism of action has potential in treating patients with substance use disorders. Tris plans to continue evaluating cebranopadol's potential to help patients break the cycle of opioid addiction. The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), has awarded Tris a five-year grant of up to $16.6 million to study cebranopadol's potential to treat opioid use disorders and substance use disorders.
Leadership and Strategic Direction
The launch of Adneuris follows Tris Pharma's May 2026 promotion of Jim Potenziano, Ph.D., to Chief Science and Development Officer, a strategic appointment that underscores the company's commitment to expanding its portfolio beyond ADHD into pain and other central nervous system disorders. Potenziano has led the Medical Affairs function at Tris and has been instrumental in building the scientific foundation supporting the company's marketed products and pipeline.
"Tris is entering an exciting period of growth and transformation," Potenziano said. "Our pipeline reflects the remarkable science and technology that defines this company. I'm honored to take on this role and to work alongside such a talented team as we advance innovative therapies that have the potential to make a meaningful difference in patients' lives."