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Pentalong

Jena University Hospital · Phase 3 active Small molecule ✓ Verified May 2026

Pentalong is a Small molecule drug developed by Jena University Hospital. It is currently in Phase 3 development. Also known as: Pentaeritrithyl tetranitrate, Pentalong® 50 mg.

Pentalong is a small molecule that activates soluble guanylate cyclase, a molecular target involved in various physiological processes. It has been studied in clinical trials for conditions such as type 2 diabetes, high-risk pregnancy, and intrauterine growth restriction.

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 namePentalong
Also known asPentaeritrithyl tetranitrate, Pentalong® 50 mg
SponsorJena University Hospital
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 3

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 Pentalong

What is Pentalong?

Pentalong is a Small molecule drug developed by Jena University Hospital.

Who makes Pentalong?

Pentalong is developed by Jena University Hospital (see full Jena University Hospital pipeline at /company/jena-university-hospital).

Is Pentalong also known as anything else?

Pentalong is also known as Pentaeritrithyl tetranitrate, Pentalong® 50 mg.

What development phase is Pentalong in?

Pentalong is in Phase 3.

Related

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