Last reviewed 2026-04-20 · How we verify

Inhaled TD139

Galecto Biotech AB · Phase 1 active Small molecule Quality 15/100

Inhaled TD139 is a Small molecule drug developed by Galecto Biotech AB. It is currently in Phase 1 development. Also known as: TD139.

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	Inhaled TD139
Also known as	TD139
Sponsor	Galecto Biotech AB
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

Cough
COVID-19
Lower Respiratory Tract Infection
Dyspnoea
Diarrhoea
Headache
Bronchitis
Productive Cough
Upper respiratory tract infection
Urinary Tract Infection
Back Pain
Idiopathic pulmonary fibrosis

Key clinical trials

DEFINE - Evaluating Therapies for COVID-19 (PHASE1, PHASE2)
A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (PHASE2)
RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients (PHASE1, PHASE2)

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:

Inhaled TD139 CI brief — competitive landscape report
Inhaled TD139 updates RSS · CI watch RSS
Galecto Biotech AB portfolio CI

Frequently asked questions about Inhaled TD139

What is Inhaled TD139?

Inhaled TD139 is a Small molecule drug developed by Galecto Biotech AB.

Who makes Inhaled TD139?

Inhaled TD139 is developed by Galecto Biotech AB (see full Galecto Biotech AB pipeline at /company/galecto-biotech-ab).

Is Inhaled TD139 also known as anything else?

Inhaled TD139 is also known as TD139.

What development phase is Inhaled TD139 in?

Inhaled TD139 is in Phase 1.

What are the side effects of Inhaled TD139?

Common side effects of Inhaled TD139 include Cough, COVID-19, Lower Respiratory Tract Infection, Dyspnoea, Diarrhoea, Headache.

Manufacturer: Galecto Biotech AB — full pipeline
Also known as: TD139

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