Last reviewed 2026-06-01 · How we verify

NTS-104 TRIS

NeuroTrauma Sciences, LLC · Phase 1 active Small molecule ✓ Verified Jun 2026

NTS-104 TRIS is a Small molecule drug developed by NeuroTrauma Sciences, LLC. It is currently in Phase 1 development. Also known as: IP.

NTS-104 TRIS is a small molecule being studied as a potential treatment for acute ischemic stroke. A single-center, randomized, placebo-controlled trial (NCT05547438) is evaluating the safety, tolerability, and pharmacokinetics of NTS-104 TRIS in healthy adults.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	NTS-104 TRIS
Also known as	IP
Sponsor	NeuroTrauma Sciences, LLC
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Single Ascending Dose Safety and Tolerability of NTS-104 Healthy Adults (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

NTS-104 TRIS CI brief — competitive landscape report
NTS-104 TRIS updates RSS · CI watch RSS
NeuroTrauma Sciences, LLC portfolio CI

Frequently asked questions about NTS-104 TRIS

What is NTS-104 TRIS?

NTS-104 TRIS is a Small molecule drug developed by NeuroTrauma Sciences, LLC.

Who makes NTS-104 TRIS?

NTS-104 TRIS is developed by NeuroTrauma Sciences, LLC (see full NeuroTrauma Sciences, LLC pipeline at /company/neurotrauma-sciences-llc).

Is NTS-104 TRIS also known as anything else?

NTS-104 TRIS is also known as IP.

What development phase is NTS-104 TRIS in?

NTS-104 TRIS is in Phase 1.

Manufacturer: NeuroTrauma Sciences, LLC — full pipeline
Also known as: IP

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing