Last reviewed 2026-05-29 · How we verify

VAD044 Part II

Vaderis Therapeutics AG · Phase 1 active Small molecule ✓ Verified May 2026

VAD044 Part II is a Small molecule drug developed by Vaderis Therapeutics AG. It is currently in Phase 1 development. Also known as: VAD044 L-Tartrate gelatin capsules.

VAD044 Part II is a randomized, placebo-controlled, double-blind study assessing the safety and efficacy of VAD044 in patients with Hereditary Hemorrhagic Telangiectasia (HHT). The study is being conducted by Vaderis Therapeutics AG as part of a proof of concept study to evaluate two doses of VAD044 in HHT patients.

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	VAD044 Part II
Also known as	VAD044 L-Tartrate gelatin capsules
Sponsor	Vaderis Therapeutics AG
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Assess Safety and Efficacy of VAD044 in HHT 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:

VAD044 Part II CI brief — competitive landscape report
VAD044 Part II updates RSS · CI watch RSS
Vaderis Therapeutics AG portfolio CI

Frequently asked questions about VAD044 Part II

What is VAD044 Part II?

VAD044 Part II is a Small molecule drug developed by Vaderis Therapeutics AG.

Who makes VAD044 Part II?

VAD044 Part II is developed by Vaderis Therapeutics AG (see full Vaderis Therapeutics AG pipeline at /company/vaderis-therapeutics-ag).

Is VAD044 Part II also known as anything else?

VAD044 Part II is also known as VAD044 L-Tartrate gelatin capsules.

What development phase is VAD044 Part II in?

VAD044 Part II is in Phase 1.

Manufacturer: Vaderis Therapeutics AG — full pipeline
Also known as: VAD044 L-Tartrate gelatin capsules

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