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Amphothalide (AMPHOTALIDE)

Phase 2 active Small molecule

Amphothalide (generic name: AMPHOTALIDE) is a drug. It is currently in Phase 2 development.

Amphothalide works by binding to a specific target, although the identity of this target is currently unknown.

Amphothalide is a small molecule modality developed by an unknown entity, currently owned by an unknown entity. Its target and drug class are unknown, and it has not been approved by the FDA for any indications. The commercial status of Amphothalide is unclear, and it is not known whether it is patented or available as a generic. Further information on its pharmacokinetic properties, such as half-life and bioavailability, is also unavailable. As a result, key safety considerations and potential side effects are unknown.

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 nameAMPHOTALIDE
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Think of Amphothalide like a key that fits into a lock. The lock is a specific part of a cell, and the key is the Amphothalide molecule. When the key fits into the lock, it can change the way the cell works, which can help to treat a disease. However, the exact details of how Amphothalide works are still unclear.

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:

Frequently asked questions about Amphothalide

What is Amphothalide?

Amphothalide (AMPHOTALIDE) is a Small molecule drug.

How does Amphothalide work?

Amphothalide works by binding to a specific target, although the identity of this target is currently unknown.

What is the generic name of Amphothalide?

AMPHOTALIDE is the generic (nonproprietary) name of Amphothalide.

What development phase is Amphothalide in?

Amphothalide is in Phase 2.

Related

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