Last reviewed 2026-05-22 · How we verify

Rhythmy (RILMAZAFONE)

Phase 2 active Small molecule ✓ Verified May 2026 Quality 19/100

Rhythmy (generic name: RILMAZAFONE) is a rilmazafone drug. It is currently in Phase 2 development for Insomnia.

RILMAZAFONE works by binding to the benzodiazepine receptor, enhancing the activity of the neurotransmitter GABA.

Rhythmy (RILMAZAFONE) is a small molecule drug in the rilmazafone class, used to treat insomnia. Its commercial status is unknown, and it is not clear if it is patented or available as a generic. The target of RILMAZAFONE is unknown, and it has been approved for use in treating insomnia. Further information on its pharmacokinetics and safety profile is not available. As a result, its use should be approached with caution.

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	RILMAZAFONE
Drug class	rilmazafone
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is like a busy city, and GABA is like a calming traffic cop. RILMAZAFONE helps the traffic cop work more effectively, which can lead to a calming effect and help you fall asleep.

Approved indications

Insomnia

Common side effects

Hepatic function abnormal

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

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

Frequently asked questions about Rhythmy

What is Rhythmy?

Rhythmy (RILMAZAFONE) is a rilmazafone drug, indicated for Insomnia.

How does Rhythmy work?

RILMAZAFONE works by binding to the benzodiazepine receptor, enhancing the activity of the neurotransmitter GABA.

What is Rhythmy used for?

Rhythmy is indicated for Insomnia.

What is the generic name of Rhythmy?

RILMAZAFONE is the generic (nonproprietary) name of Rhythmy.

What drug class is Rhythmy in?

Rhythmy belongs to the rilmazafone class. See all rilmazafone drugs at /class/rilmazafone.

What development phase is Rhythmy in?

Rhythmy is in Phase 2.

What are the side effects of Rhythmy?

Common side effects of Rhythmy include Hepatic function abnormal.

Drug class: All rilmazafone drugs
Therapeutic area: All drugs in Neuroscience
Indication: Drugs for Insomnia

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