Last reviewed 2026-05-27 · How we verify

MY006 Low Dose

Mabylon AG · Phase 1 active Small molecule ✓ Verified May 2026

MY006 Low Dose is a Small molecule drug developed by Mabylon AG. It is currently in Phase 1 development.

MY006 Low Dose is being studied in a clinical trial for the treatment of peanut allergies. The exact mechanism of MY006 Low Dose is currently unknown.

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	MY006 Low Dose
Sponsor	Mabylon 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

Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy (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:

MY006 Low Dose CI brief — competitive landscape report
MY006 Low Dose updates RSS · CI watch RSS
Mabylon AG portfolio CI

Frequently asked questions about MY006 Low Dose

What is MY006 Low Dose?

MY006 Low Dose is a Small molecule drug developed by Mabylon AG.

Who makes MY006 Low Dose?

MY006 Low Dose is developed by Mabylon AG (see full Mabylon AG pipeline at /company/mabylon-ag).

What development phase is MY006 Low Dose in?

MY006 Low Dose is in Phase 1.

Manufacturer: Mabylon AG — full pipeline

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