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Amidrine (OCTODRINE)

Phase 2 active Small molecule

Amidrine (generic name: OCTODRINE) is a octodrine drug. It is currently in Phase 2 development.

Amidrine is believed to work by stimulating the central nervous system.

Amidrine, also known as Octodrine, is a small molecule drug of the octodrine class. Its exact target and mechanism of action are unknown, but it is believed to work by stimulating the central nervous system. Amidrine is not FDA-approved for any indications, and its commercial status is unclear. As a result, there is limited information available on its safety profile and pharmacokinetic properties. Further research is needed to fully understand the potential benefits and risks of this compound.

Likelihood of approval
12.3% 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).
  • CNS / neurology attrition -3.0pp
    CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
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 nameOCTODRINE
Drug classoctodrine
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Imagine your brain as a computer - Amidrine is thought to be like a software update that helps increase alertness and focus by enhancing the communication between different parts of the brain. This can lead to improved mental clarity and a sense of energy, but more research is needed to confirm its effects and potential side effects.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

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

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Amidrine

What is Amidrine?

Amidrine (OCTODRINE) is a octodrine drug.

How does Amidrine work?

Amidrine is believed to work by stimulating the central nervous system.

What is the generic name of Amidrine?

OCTODRINE is the generic (nonproprietary) name of Amidrine.

What drug class is Amidrine in?

Amidrine belongs to the octodrine class. See all octodrine drugs at /class/octodrine.

What development phase is Amidrine in?

Amidrine is in Phase 2.

Related

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