Last reviewed 2026-05-30 · How we verify

ALT-100 mAb

Aqualung Therapeutics Corp. · Phase 2 active Small molecule ✓ Verified May 2026

ALT-100 mAb is a Small molecule drug developed by Aqualung Therapeutics Corp.. It is currently in Phase 2 development.

ALT-100 mAb is a monoclonal antibody that targets an unspecified molecular target.

ALT-100 mAb is a monoclonal antibody being studied in a clinical trial for the treatment of Acute Respiratory Distress Syndrome (ARDS). According to ClinicalTrials.gov, the study, titled "PUERTA", is a randomized, double-blind, placebo-controlled trial assessing the safety and efficacy of ALT-100 mAb in participants with moderate/severe ARDS.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	ALT-100 mAb
Sponsor	Aqualung Therapeutics Corp.
Modality	Small molecule
Phase	Phase 2

Mechanism of action

ALT-100 mAb is a monoclonal antibody designed to modulate the immune system. However, the exact mechanism of action is not well understood at this time.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Study of Safety and Efficacy of ALT-100mAb in Participants With Moderate/Severe ARDS (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:

ALT-100 mAb CI brief — competitive landscape report
ALT-100 mAb updates RSS · CI watch RSS
Aqualung Therapeutics Corp. portfolio CI

Frequently asked questions about ALT-100 mAb

What is ALT-100 mAb?

ALT-100 mAb is a Small molecule drug developed by Aqualung Therapeutics Corp..

How does ALT-100 mAb work?

ALT-100 mAb is a monoclonal antibody that targets an unspecified molecular target.

Who makes ALT-100 mAb?

ALT-100 mAb is developed by Aqualung Therapeutics Corp. (see full Aqualung Therapeutics Corp. pipeline at /company/aqualung-therapeutics-corp).

What development phase is ALT-100 mAb in?

ALT-100 mAb is in Phase 2.

Manufacturer: Aqualung Therapeutics Corp. — full pipeline

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