Last reviewed 2026-05-14 · How we verify

Luvistin (HISTAPYRRODINE)

Phase 2 active Small molecule

Luvistin (generic name: HISTAPYRRODINE) is a histapyrrodine drug. It is currently in Phase 2 development.

Luvistin works by blocking histamine receptors in the body.

Luvistin, also known as histapyrrodine, is a small molecule drug of unknown target and class. Its commercial status and approved indications are currently unknown. As a histapyrrodine, it is a histamine antagonist, but further information is needed to provide a comprehensive summary. Further research is required to understand its mechanism of action, pharmacokinetics, and safety profile. Its development and ownership history are also unclear.

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	HISTAPYRRODINE
Drug class	histapyrrodine
Modality	Small molecule
Therapeutic area	Respiratory
Phase	Phase 2

Mechanism of action

Histamine is a chemical that can cause allergic reactions, itching, and other symptoms. By blocking histamine receptors, Luvistin can help reduce these symptoms. This can be especially helpful for people with conditions like allergies or asthma.

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:

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

Frequently asked questions about Luvistin

What is Luvistin?

Luvistin (HISTAPYRRODINE) is a histapyrrodine drug.

How does Luvistin work?

Luvistin works by blocking histamine receptors in the body.

What is the generic name of Luvistin?

HISTAPYRRODINE is the generic (nonproprietary) name of Luvistin.

What drug class is Luvistin in?

Luvistin belongs to the histapyrrodine class. See all histapyrrodine drugs at /class/histapyrrodine.

What development phase is Luvistin in?

Luvistin is in Phase 2.

Drug class: All histapyrrodine drugs
Therapeutic area: All drugs in Respiratory

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