Last reviewed 2026-05-30 · How we verify

Lactofiltrum

Avva Rus, JSC · Phase 2 active Small molecule ✓ Verified May 2026

Lactofiltrum is a Small molecule drug developed by Avva Rus, JSC. It is currently in Phase 2 development. Also known as: Lactulose, Lignin.

Lactofiltrum is a treatment being studied for Atopic Dermatitis and Bacterial Vaginosis, with a pilot study conducted to evaluate its efficacy and safety in treating Atopic Dermatitis in adults. The study, which compared Lactofiltrum to a placebo, was a Phase II double-blind, placebo-controlled, randomized comparative multicentered study.

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	Lactofiltrum
Also known as	Lactulose, Lignin
Sponsor	Avva Rus, JSC
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Pilot Study of Lactofiltrum to Treat Atopic Dermatitis in Adults (PHASE2, PHASE3)
A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis (PHASE2, PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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

Lactofiltrum CI brief — competitive landscape report
Lactofiltrum updates RSS · CI watch RSS
Avva Rus, JSC portfolio CI

Frequently asked questions about Lactofiltrum

What is Lactofiltrum?

Lactofiltrum is a Small molecule drug developed by Avva Rus, JSC.

Who makes Lactofiltrum?

Lactofiltrum is developed by Avva Rus, JSC (see full Avva Rus, JSC pipeline at /company/avva-rus-jsc).

Is Lactofiltrum also known as anything else?

Lactofiltrum is also known as Lactulose, Lignin.

What development phase is Lactofiltrum in?

Lactofiltrum is in Phase 2.

Manufacturer: Avva Rus, JSC — full pipeline
Therapeutic area: All drugs in Other
Also known as: Lactulose, Lignin

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