Last reviewed 2026-05-18 · How we verify

SHX-001 Active low dose

Shenox Pharmaceuticals, LLC · Phase 1 active Small molecule Quality 0/100

SHX-001 Active low dose is a Small molecule drug developed by Shenox Pharmaceuticals, LLC. It is currently in Phase 1 development. Also known as: Ketamine transdermal patch.

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	SHX-001 Active low dose
Also known as	Ketamine transdermal patch
Sponsor	Shenox Pharmaceuticals, 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

Ketamine for Major Depressive Disorder (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:

SHX-001 Active low dose CI brief — competitive landscape report
SHX-001 Active low dose updates RSS · CI watch RSS
Shenox Pharmaceuticals, LLC portfolio CI

Frequently asked questions about SHX-001 Active low dose

What is SHX-001 Active low dose?

SHX-001 Active low dose is a Small molecule drug developed by Shenox Pharmaceuticals, LLC.

Who makes SHX-001 Active low dose?

SHX-001 Active low dose is developed by Shenox Pharmaceuticals, LLC (see full Shenox Pharmaceuticals, LLC pipeline at /company/shenox-pharmaceuticals-llc).

Is SHX-001 Active low dose also known as anything else?

SHX-001 Active low dose is also known as Ketamine transdermal patch.

What development phase is SHX-001 Active low dose in?

SHX-001 Active low dose is in Phase 1.

Manufacturer: Shenox Pharmaceuticals, LLC — full pipeline
Also known as: Ketamine transdermal patch

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