Last reviewed 2026-04-20 · How we verify

Milibis (GLYCOBIARSOL)

Phase 2 active Small molecule

Milibis (generic name: GLYCOBIARSOL) is a glycobiarsol drug. It is currently in Phase 2 development for Acute amebiasis.

Milibis works by inhibiting the growth and replication of the amoeba Entamoeba histolytica.

Milibis, also known as GlycoBIARSOL, is a small molecule drug in the glycobiarsol class. It is used to treat acute amebiasis, a parasitic infection caused by the amoeba Entamoeba histolytica. The commercial status of Milibis is unclear, and it is not known whether it is patented or available as a generic. Further information on its pharmacokinetics and safety profile is also lacking. As a result, its use should be approached with caution and under the guidance of a qualified healthcare professional.

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	GLYCOBIARSOL
Drug class	glycobiarsol
Modality	Small molecule
Therapeutic area	Metabolic
Phase	Phase 2

Mechanism of action

In simple terms, Milibis stops the amoeba from multiplying and causing harm in the body. This allows the body's natural defenses to fight off the infection and recover. By targeting the parasite directly, Milibis helps to alleviate symptoms and prevent complications.

Approved indications

Acute amebiasis

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:

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

Frequently asked questions about Milibis

What is Milibis?

Milibis (GLYCOBIARSOL) is a glycobiarsol drug, indicated for Acute amebiasis.

How does Milibis work?

Milibis works by inhibiting the growth and replication of the amoeba Entamoeba histolytica.

What is Milibis used for?

Milibis is indicated for Acute amebiasis.

What is the generic name of Milibis?

GLYCOBIARSOL is the generic (nonproprietary) name of Milibis.

What drug class is Milibis in?

Milibis belongs to the glycobiarsol class. See all glycobiarsol drugs at /class/glycobiarsol.

What development phase is Milibis in?

Milibis is in Phase 2.

Drug class: All glycobiarsol drugs
Therapeutic area: All drugs in Metabolic
Indication: Drugs for Acute amebiasis

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