Last reviewed 2026-04-20 · How we verify

Calmixen (PIMETHIXENE)

Phase 2 active Small molecule

Calmixen (generic name: PIMETHIXENE) is a pimethixene drug. It is currently in Phase 2 development.

Calmixen works by inhibiting the activity of Histone-lysine N-methyltransferase SETD7, an enzyme involved in gene regulation.

Calmixen (Pimethixene) is a small molecule drug that targets Histone-lysine N-methyltransferase SETD7. It is classified as a pimethixene, but its commercial status and approved indications are unknown. The mechanism of action and pharmacokinetic properties of Calmixen are also not well-documented. Further research is needed to understand its potential therapeutic applications and safety profile.

Likelihood of approval

15.3% 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).

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	PIMETHIXENE
Drug class	pimethixene
Target	5-hydroxytryptamine receptor 2A, Histone-lysine N-methyltransferase SETD7, Transcriptional activator protein luxR
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of gene regulation like a light switch. Histone-lysine N-methyltransferase SETD7 is like a dimmer switch that adjusts how much light is turned on or off. Calmixen flips the switch to a different setting, which can affect how genes are expressed and potentially treat certain diseases.

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:

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

Frequently asked questions about Calmixen

What is Calmixen?

Calmixen (PIMETHIXENE) is a pimethixene drug.

How does Calmixen work?

Calmixen works by inhibiting the activity of Histone-lysine N-methyltransferase SETD7, an enzyme involved in gene regulation.

What is the generic name of Calmixen?

PIMETHIXENE is the generic (nonproprietary) name of Calmixen.

What drug class is Calmixen in?

Calmixen belongs to the pimethixene class. See all pimethixene drugs at /class/pimethixene.

What development phase is Calmixen in?

Calmixen is in Phase 2.

What does Calmixen target?

Calmixen targets 5-hydroxytryptamine receptor 2A, Histone-lysine N-methyltransferase SETD7, Transcriptional activator protein luxR and is a pimethixene.

Drug class: All pimethixene drugs
Target: All drugs targeting 5-hydroxytryptamine receptor 2A, Histone-lysine N-methyltransferase SETD7, Transcriptional activator protein luxR
Therapeutic area: All drugs in Other

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