TRV045

About Diabetic Neuropathic Pain

Diabetic neuropathy is a common complication of both type 1 and type 2 diabetes, with pain in the extremities being one of the main symptoms. Other symptoms may include numbness, tingling, allodynia and hyperalgesia.1 Diabetic neuropathic pain is usually characterized as moderate to severe in nature and can substantially affect patients’ quality of life as well as their social and psychological well-being.2

Approximately 25% of people with diabetes – totaling over 5 million people in the U.S. –  are affected by DNP.3,4 During their lifetime, nearly 50% of diabetic patients may experience symptoms of DNP.5 There are few approved therapeutic options for neuropathic pain associated with DNP, and currently available agents do not provide adequate analgesia for an estimated 50% of patients due to lack of efficacy.6,7

Program Molecular Target Therapeutic Target Current Phase PC PH1 PH2 PH3 NDA Approved
TRV045 S1P receptor Diabetic neuropathic pain PC Oral PC in progress PH1 not started PH2 not started PH3 not started NDA not started Approved not started
TRV045 is an Investigational Product not approved by FDA for distribution in the US.

About TRV045

Trevena is currently developing a novel, selective sphingosine-1-phosphate subtype 1 receptor (S1P1R) modulator, TRV045, as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. Through a collaboration with the National Institutes of Health, Trevena is also exploring TRV045 as a potential treatment for epilepsy.

S1P receptors are located throughout the body, including the central nervous system, where they are believed to play a role in modulating neurotransmission and membrane excitability.

Trevena's discovery efforts have identified a family of compounds that are highly selective for the S1P1R. TRV045 reversed thermal hyperalgesia, a measure of neuropathic pain, in nonclinical models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy. Unlike existing S1PR modulators, TRV045 did not cause lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses in nonclinical studies.

Program Molecular Target Therapeutic Target Current Phase PC PH1 PH2 PH3 NDA Approved
TRV045 S1P receptor Diabetic neuropathic pain PC Oral PC in progress PH1 not started PH2 not started PH3 not started NDA not started Approved not started
  1. Juster-Swityk K, Smith AG. Updates in Diabetic Peripheral Neuropathy. F1000 Research 2016;738.
  2. Quattrini C, Tesfaye S. Understanding the impact of painful diabetic neuropathy. Diabetes Metab Res Rev. 2003 Jan-Feb;19 Suppl 1:S2-8. doi: 10.1002/dmrr.360. PMID: 12577252.
  3. Rosenberger et al., Journal of Neural Transmission, 2020 and CDC National Diabetes Statistics Report, 2020.
  4. Shillo et al., Current Diabetes Reports, 2019.
  5. Hicks CW, Selvin E. Epidemiology of Peripheral Neuropathy and Lower Extremity Disease in Diabetes. Current Diabetes Reports 2019;19:86
  6. American Diabetes Association
  7. FDA product labels for Lyrica, Lyrica CR, Cymbalta, Nucynta ER, and Qutenza, Tesfaye et.al. Pain (2013).