Last reviewed 2026-05-14 · How we verify

Bromadryl (EMBRAMINE)

Phase 2 active Small molecule

Bromadryl (generic name: EMBRAMINE) is a embramine drug. It is currently in Phase 2 development.

Bromadryl works by affecting the levels of certain chemicals in the brain.

Bromadryl, also known as EMBRAMINE, is a small molecule drug in the embramine class. Its exact target is unknown, but it is used to treat certain conditions. The commercial status of Bromadryl is unclear, and it may be patented or have generic manufacturers. Key safety considerations are not well-documented. Further research is needed to fully understand this medication.

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	EMBRAMINE
Drug class	embramine
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is a complex computer with many different chemical signals. Bromadryl helps regulate these signals, which can help treat conditions where the signals are out of balance. This can lead to feelings of calmness and reduced anxiety.

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:

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

Frequently asked questions about Bromadryl

What is Bromadryl?

Bromadryl (EMBRAMINE) is a embramine drug.

How does Bromadryl work?

Bromadryl works by affecting the levels of certain chemicals in the brain.

What is the generic name of Bromadryl?

EMBRAMINE is the generic (nonproprietary) name of Bromadryl.

What drug class is Bromadryl in?

Bromadryl belongs to the embramine class. See all embramine drugs at /class/embramine.

What development phase is Bromadryl in?

Bromadryl is in Phase 2.

Drug class: All embramine drugs
Therapeutic area: All drugs in Neuroscience

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