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Abovis (ACLATONIUM)

Phase 2 active Small molecule Quality 23/100

Abovis (generic name: ACLATONIUM) is a aclatonium drug. It is currently in Phase 2 development for Biliary dyskinesia, Chronic gastritis.

Abovis works by binding to the muscarinic acetylcholine receptor, a protein that plays a key role in regulating various bodily functions.

Abovis (ACLATONIUM) is a small molecule drug that targets the muscarinic acetylcholine receptor. It is used to treat biliary dyskinesia and chronic gastritis. The commercial status of Abovis is currently unknown, and it is not clear if it is patented or available as a generic medication. As a pharma professional, it is essential to consider the potential safety implications of Abovis, including its mechanism of action and potential side effects. Further research is needed to fully understand the properties and clinical applications of Abovis.

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 nameACLATONIUM
Drug classaclatonium
TargetMuscarinic acetylcholine receptor
ModalitySmall molecule
Therapeutic areaDermatology
PhasePhase 2

Mechanism of action

Imagine your body's nervous system as a complex network of messengers. Abovis helps to regulate the flow of these messengers, specifically targeting the muscarinic acetylcholine receptor to treat conditions like biliary dyskinesia and chronic gastritis.

Approved indications

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:

Frequently asked questions about Abovis

What is Abovis?

Abovis (ACLATONIUM) is a aclatonium drug, indicated for Biliary dyskinesia, Chronic gastritis.

How does Abovis work?

Abovis works by binding to the muscarinic acetylcholine receptor, a protein that plays a key role in regulating various bodily functions.

What is Abovis used for?

Abovis is indicated for Biliary dyskinesia, Chronic gastritis.

What is the generic name of Abovis?

ACLATONIUM is the generic (nonproprietary) name of Abovis.

What drug class is Abovis in?

Abovis belongs to the aclatonium class. See all aclatonium drugs at /class/aclatonium.

What development phase is Abovis in?

Abovis is in Phase 2.

What does Abovis target?

Abovis targets Muscarinic acetylcholine receptor and is a aclatonium.

Related

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