Last reviewed 2026-06-03 · How we verify

Alfadryl (MOXASTINE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Alfadryl (generic name: MOXASTINE) is a moxastine drug. It is currently in Phase 2 development.

Alfadryl works by binding to the histamine H1 receptor, blocking the action of histamine and reducing symptoms of allergic reactions.

Alfadryl is a small molecule medication with the synonyms .ALPHA.-METHYLDIPHENHYDRAMINE, MOXASTINA, and MOXASTINE.

Likelihood of approval

12.3% 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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

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	MOXASTINE
Drug class	moxastine
Target	Histamine H1 receptor
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of histamine like a messenger that tells your body to react to an allergen. When histamine binds to its receptor, it triggers a response that can cause symptoms like itching, sneezing, and runny nose. Alfadryl blocks this messenger, preventing the allergic reaction from happening.

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:

Alfadryl CI brief — competitive landscape report
Alfadryl updates RSS · CI watch RSS

Frequently asked questions about Alfadryl

What is Alfadryl?

Alfadryl (MOXASTINE) is a moxastine drug.

How does Alfadryl work?

Alfadryl works by binding to the histamine H1 receptor, blocking the action of histamine and reducing symptoms of allergic reactions.

What is the generic name of Alfadryl?

MOXASTINE is the generic (nonproprietary) name of Alfadryl.

What drug class is Alfadryl in?

Alfadryl belongs to the moxastine class. See all moxastine drugs at /class/moxastine.

What development phase is Alfadryl in?

Alfadryl is in Phase 2.

What does Alfadryl target?

Alfadryl targets Histamine H1 receptor and is a moxastine.

Drug class: All moxastine drugs
Target: All drugs targeting Histamine H1 receptor
Therapeutic area: All drugs in Neuroscience

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