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Cellegesic
Cellegesic is a Small molecule drug developed by Forest Laboratories. It is currently in Phase 3 development. Also known as: 0.4% nitroglycerin ointment, Rectogesic.
Cellegesic is being studied in clinical trials for various conditions, including Non-small Cell Lung Cancer, Brain Metastases, EGFR Gene Mutation, Catheter-Associated Infections, and Catheter-Related Infections. The treatments being tested include Nitroglycerin, Nitroglycerin-citrate-ethanol (NiCE), and Saline Pd/Pa, with one study comparing concurrent Nitroglycerin with radiation therapy to conventional radiation therapy in patients with lung cancer.
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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).
| 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 name | Cellegesic |
|---|---|
| Also known as | 0.4% nitroglycerin ointment, Rectogesic |
| Sponsor | Forest Laboratories |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Glyceryl Trinitrate Gel Phonophoresis on Planter Fasciiatis (NA)
- Effect of Topically-applied Milrinone or Nitroglycerin on Internal Mammary Artery Free Flow (PHASE3)
- Subcutaneous Nitroglycerin to Facilitate Trans-radial Access. (PHASE4)
- Evaluating the Effects of Nitroglycerin on Heart Function and Urinary Output in Patients With Acute Heart Failure (PHASE4)
- Mannitol Versus Nitroglycerin for Kidney Injury Prevention in Robotic-assisted Radical Prostatectomy or Cystectomy (NA)
- Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule (NA)
- A Study to Learn About How Safe Nitroglycerin is and How it Affects the Body When Taken Along With Nurandociguat in People With Coronary Artery Disease (PHASE1)
- Optimized Strict Fluid Management Helps Improve Endpoints After Liver Dissection (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial 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:
- Cellegesic CI brief — competitive landscape report
- Cellegesic updates RSS · CI watch RSS
- Forest Laboratories portfolio CI
Frequently asked questions about Cellegesic
What is Cellegesic?
Who makes Cellegesic?
Is Cellegesic also known as anything else?
What development phase is Cellegesic in?
Related
- Manufacturer: Forest Laboratories — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: 0.4% nitroglycerin ointment, Rectogesic
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing