Last reviewed · How we verify

Dinitrochlorhydrin (CLONITRATE)

Phase 2 active Small molecule ✓ Verified May 2026

Dinitrochlorhydrin (generic name: CLONITRATE) is a drug. It is currently in Phase 2 development for Angina pectoris.

Clonitrate works by relaxing blood vessels to improve blood flow to the heart.

Dinitrochlorhydrin is a small molecule with the synonyms CLONITRATE, CLONITRATO, and DYLATE.

Likelihood of approval
13.3% 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).
  • Cardiovascular Phase 3 risk -2.0pp
    Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
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 nameCLONITRATE
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 2

Mechanism of action

Imagine your blood vessels as roads that allow traffic to flow to your heart. Clonitrate helps to widen these roads, making it easier for blood to reach your heart and reducing the strain on your heart muscle. This can help to alleviate symptoms of angina pectoris, such as chest pain and shortness of breath.

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 Dinitrochlorhydrin

What is Dinitrochlorhydrin?

Dinitrochlorhydrin (CLONITRATE) is a Small molecule drug, indicated for Angina pectoris.

How does Dinitrochlorhydrin work?

Clonitrate works by relaxing blood vessels to improve blood flow to the heart.

What is Dinitrochlorhydrin used for?

Dinitrochlorhydrin is indicated for Angina pectoris.

What is the generic name of Dinitrochlorhydrin?

CLONITRATE is the generic (nonproprietary) name of Dinitrochlorhydrin.

What development phase is Dinitrochlorhydrin in?

Dinitrochlorhydrin is in Phase 2.

Related

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