|Phase||Molecular Target||Therapeutic Target||Preclinical Phase 1 Phase 2 Phase 3 NDA|
|Oliceridine injection||NDA||Mu-receptor||Moderate to Severe Acute Pain||intravenous|
|TRV734||Phase 1||Mu-receptor||Moderate to Severe Pain||oral|
We are developing innovative therapies for patients affected by Central Nervous System (CNS) conditions.
Oliceridine injection, our lead product candidate, is a G protein-selective agonist at the mu-opioid receptor being developed for the management of moderate to severe acute pain in hospitals or other controlled clinical settings where intravenous, or IV, opioid therapy is warranted. It is a new chemical entity with a novel mechanism of action at the mu-opioid receptor that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. In late 2017, we submitted the oliceridine new drug application, or NDA, to the United States Food and Drug Administration, or FDA. On November 2, 2018, the FDA issued a complete response letter, or CRL, with respect to our NDA for oliceridine.
TRV250 is a G protein-selective agonist at the delta-opioid receptor being developed for the acute treatment of migraine. It is a new chemical entity with a first-in-class, novel mechanism of action at the delta-opioid receptor. In June 2018, we announced the successful completion of our first-in-human Phase 1 study of TRV250. Data from this healthy volunteer study showed safety, tolerability, and pharmacokinetics supporting the advancement of TRV250 to Phase 2 proof of concept evaluation in patients. TRV250 may also have utility in a range of other CNS indications.
TRV734 is a G protein-selective agonist at the mu-opioid receptor being developed for the oral management of opioid use disorder. We are collaborating with the National Institute on Drug Abuse, or NIDA, to further evaluate TRV734 for the management of opioid use disorder. In December 2018, we announced that positive preclinical data were featured in a presentation by NIDA at the 57th Annual Meeting of the American College of Neuropsychopharmacology, which demonstrated efficacy in an animal model of opioid relapse. The nonclinical and Phase 1 data for TRV734 suggest that it may provide an improved option for patients receiving maintenance therapy for opioid use disorder. We intend to continue to focus our efforts for TRV734 on securing a development and commercialization partner for this asset.
TRV045 is a novel S1P modulator that we have recently identified as potentially offering a new, non-opioid approach to managing chronic pain and other CNS conditions. We anticipate beginning investigational new drug, or IND, enabling work in 2019, and we will continue to evaluate the progression of this asset to an IND, either by ourselves or with a partner.
All Investigational Products are not approved by FDA for distribution in the US.
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