Investigational Drug

DENVER — A novel regimen of doravirine and islatravir was noninferior to a common HIV therapy as an initial HIV treatment, according to phase 3 data shared at the Conference on Opportunistic Infections and Retroviruses.

LONG BEACH, Calif. — Researchers reported results from a phase 1b/2a placebo-controlled study of DISC-0974, an anti-hemojuvelin antibody to treat anemia in patients with chronic kidney disease.

DENVER — Phase 2 study data showed that a once-weekly oral regimen of an investigational two-drug HIV treatment was well tolerated among patients with HIV and allowed them to maintain viral suppression.

Evenamide, an investigational drug for treatment-resistant schizophrenia, was linked with “increasing, sustained and clinically significant” symptom improvements in a recent study, according to a manufacturer press release.

Stoke Therapeutics Inc. announced the FDA will allow administration of a higher single dose of its investigational drug STK-001 in its ongoing phase 1/2a MONARCH study of children and adolescents with Dravet syndrome.

The FDA granted investigational new drug clearance to Transcenta Holding Limited for TST004, its humanized monoclonal antibody that attacks the enzyme contributing to IgA nephropathy development, according to a press release.

The FDA has granted investigational drug designation to Ananda Scientific Inc. for Nantheia ATL5, a liquid augmentative cannabidiol-based treatment for opioid use disorder, according to a company press release.

The second of two phase 3 studies evaluating NOV03 as a first-in-class investigational drug for treatment of signs and symptoms of dry eye disease associated with meibomian gland dysfunction has been initiated.

VANCOUVER, British Columbia – Results from phase 2 and phase 3 trials showed that tivanisiran 1.125% significantly improved ocular discomfort/pain and conjunctival hyperemia in patients with dry eye and also confirmed its safety profile.