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Heraclin (BERGAPTEN)

Phase 3 active Small molecule Quality 34/100

Heraclin (generic name: BERGAPTEN) is a bergapten drug. It is currently in Phase 3 development.

Heraclin works by inhibiting the enzyme Cytochrome P450 1A1, which plays a role in the metabolism of various substances in the body.

Heraclin, also known as Bergapten, is a small molecule drug that targets Cytochrome P450 1A1. It belongs to the bergapten drug class, but its commercial status and approved indications are unknown. The mechanism of action and pharmacokinetic properties of Heraclin are also not well-documented. As a result, it is difficult to provide a comprehensive summary of this compound. Further research is needed to understand its potential therapeutic applications and safety profile.

Likelihood of approval
58.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% 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 2028–2030
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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 nameBERGAPTEN
Drug classbergapten
TargetTaste receptor type 2 member 10, Cytochrome P450 1A1, Amine oxidase [flavin-containing] A
ModalitySmall molecule
Therapeutic areaMetabolic
PhasePhase 3

Mechanism of action

Think of Heraclin like a traffic cop that helps control the flow of chemicals in your body. By blocking the enzyme Cytochrome P450 1A1, Heraclin can affect how your body processes certain substances, which may help treat certain conditions. However, more research is needed to understand how this works and what effects it may have on the body.

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 Heraclin

What is Heraclin?

Heraclin (BERGAPTEN) is a bergapten drug.

How does Heraclin work?

Heraclin works by inhibiting the enzyme Cytochrome P450 1A1, which plays a role in the metabolism of various substances in the body.

What is the generic name of Heraclin?

BERGAPTEN is the generic (nonproprietary) name of Heraclin.

What drug class is Heraclin in?

Heraclin belongs to the bergapten class. See all bergapten drugs at /class/bergapten.

What development phase is Heraclin in?

Heraclin is in Phase 3.

What does Heraclin target?

Heraclin targets Taste receptor type 2 member 10, Cytochrome P450 1A1, Amine oxidase [flavin-containing] A and is a bergapten.

Related

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