Last reviewed 2026-05-26 · How we verify

DGX-001 Dose 2

Digestome Therapeutics · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

DGX-001 Dose 2 is a Small molecule drug developed by Digestome Therapeutics. It is currently in Phase 1 development. Also known as: DGX-001.

DGX-001 is a small molecule being studied in a Phase 1 clinical trial for the treatment of Depressive Disorder. The trial is assessing the safety, tolerability, and pharmacokinetics of DGX-001 in a randomized, double-blind, placebo-controlled study with escalating doses.

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	DGX-001 Dose 2
Also known as	DGX-001
Sponsor	Digestome Therapeutics
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

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

DGX-001 Dose 2 CI brief — competitive landscape report
DGX-001 Dose 2 updates RSS · CI watch RSS
Digestome Therapeutics portfolio CI

Frequently asked questions about DGX-001 Dose 2

What is DGX-001 Dose 2?

DGX-001 Dose 2 is a Small molecule drug developed by Digestome Therapeutics.

Who makes DGX-001 Dose 2?

DGX-001 Dose 2 is developed by Digestome Therapeutics (see full Digestome Therapeutics pipeline at /company/digestome-therapeutics).

Is DGX-001 Dose 2 also known as anything else?

DGX-001 Dose 2 is also known as DGX-001.

What development phase is DGX-001 Dose 2 in?

DGX-001 Dose 2 is in Phase 1.

Manufacturer: Digestome Therapeutics — full pipeline
Also known as: DGX-001

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