Drugs / NV-5138
last change Jan 2026 re-read 3 minutes ago

NV-5138

also known as mefluleucine

Small molecule

Developed for
major depressive disorder
Investigated by
Navitor Pharmaceuticals, Inc. · Supernus Pharmaceuticals, Inc.

Trials 5

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT05152680 Nov → Dec 2021 — Navitor Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT05384977 Nov → Dec 2021 — Supernus Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT03606395 Jun 2018 → Jun 2019 — Navitor Pharmaceuticals, Inc. Completed No outcome recorded
Phase 22 trials · 1 missed
Phase 2 NCT06235905 Feb → Aug 2024 major depressive disorder Navitor Pharmaceuticals, Inc. Completed No outcome recorded
Phase 2 NCT05066672 Jan 2022 → Jan 2025 — Navitor Pharmaceuticals, Inc. Completed Missed primary

Press releases naming this drug 1 release

DateIssuerRelease
2020-04-21 Supernus Pharmaceuticals, Inc. Supernus and Navitor Announce Development and Option Agreement for Orally Active mTORC1 Activator NV-5138 supernus.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as NV-5138 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03606395 ↗
4

NCT05066672 ↗

NCT05384977 ↗

NCT06235905 ↗

NCT05152680 ↗

Known as mefluleucine “assessing rapid-acting effects of NV-5138 (mefluleucine), an intracellular enhancer of mechanistic target of rapamycin 1 synaptic signaling, for treatment-resistant depression.” PMID 41512716 ↗ Jan 2026
Action Activate “an intracellular enhancer of mechanistic target of rapamycin 1 synaptic signaling” PMID 41512716 ↗ Jan 2026
Modality Small molecule — CHEMBL4650303 ↗
Route Oral “administered as an oral solution” NCT03606395 ↗