|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|
Oliceridine injection was designed to optimize opioid receptor pharmacology using Trevena’s proprietary platform to deliver an improved analgesic profile compared to conventional intravenous (IV) opioids. Oliceridine injection is the first G Protein-Biased Ligand at the μ-opioid receptor, and is in development for the management of moderate-to-severe acute pain where IV therapy is preferred.
In February 2016, the FDA granted Breakthrough Therapy status to oliceridine injection. This designation is granted by the FDA to new therapies intended to treat serious conditions and for which preliminary clinical evidence indicates that the drug may demonstrate substantial clinical improvement over available therapies. In January, 2018, we announced that FDA has accepted the oliceridine injection new drug application for review with a Prescription Drug User Fee Act review date of November 2, 2018.
Oliceridine injection is an investigational product not approved by FDA for distribution in the US.
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