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Colyte
Colyte is a Small molecule drug developed by US Department of Veterans Affairs. It is currently in Phase 2 development. Also known as: Golytely.
Colyte is a small molecule laxative used to treat constipation, typically taken by mouth, with benefits usually occurring within three days. It is indicated for various conditions including Liver Diseases, Hepatocellular Cancer, Endstage Liver Disease, Liver Cirrhosis, and Colorectal Cancer, and is also used in living donor liver transplantation for donor pain management.
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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).
| 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 name | Colyte |
|---|---|
| Also known as | Golytely |
| Sponsor | US Department of Veterans Affairs |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- MoviPrep® Versus GoLYTELY® Bowel Preparation in Hospitalized Patients Undergoing Colonoscopy (PHASE4)
- Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease (NA)
- Colonoscopy Bowel Prep Comparison Among Diabetic Patients (PHASE4)
- Cleansing Options in Out-Patient Setting to Improve Tolerance (COOP SIT) Trial (PHASE4)
- Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen (PHASE4)
- The Study on the Effect of Different Administration Methods of Simethicone in Reducing Bubbles During Bowel Preparation (PHASE4)
- Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens (PHASE4)
- Improving Outpatient Colonoscopy Bowel Prep with the Orton Score (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:
- Colyte CI brief — competitive landscape report
- Colyte updates RSS · CI watch RSS
- US Department of Veterans Affairs portfolio CI
Frequently asked questions about Colyte
What is Colyte?
Who makes Colyte?
Is Colyte also known as anything else?
What development phase is Colyte in?
Related
- Manufacturer: US Department of Veterans Affairs — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Golytely
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing