TNX-103 (oral levosimendan)

TNX-103 (oral levosimendan) is a TENAX THERAPEUTICS, INC. program. Every date links its source.

TENX catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: TENAX THERAPEUTICS, INC. (TENX). Review status: Phase 3 LEVEL did not meet its primary endpoint: patients walked 3.5 metres further than placebo at Week 12 (p=0.63), a difference small enough to be chance; the key secondary (KCCQ-TSS) was also not met. A prespecified subgroup with baseline 6MWD under 333 m improved 26.3 m (nominal p=0.0112) and NT-proBNP fell 49% versus placebo (nominal p<0.0001), but the company states: 'Nominal p-values are not adjusted for multiplicity and these analyses do not establish efficacy.' Tenax intends to request a Type C meeting with FDA. Full results were a Late-Breaking Clinical Science presentation at ESC Congress 2026 (Munich, Aug 28-31). Note: LEVEL-2 is a separate, still-running Phase 3 of the same drug (enrollment completing end of 2027) -- this row previously mis-named the trial. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

Questions

When is TNX-103 (oral levosimendan)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for TNX-103 (oral levosimendan); no FDA decisions are on record below.

What happened at TNX-103 (oral levosimendan)'s most recent FDA decision?

No FDA decision for TNX-103 (oral levosimendan) is in our archive yet.

Who makes TNX-103 (oral levosimendan)?

TENAX THERAPEUTICS, INC. (TENX).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.