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Delzicol
Delzicol is a Small molecule drug developed by Holy Stone Healthcare Co., Ltd. It is currently in Phase 1 development. Also known as: Mesalamine 400 mg.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Delzicol |
|---|---|
| Also known as | Mesalamine 400 mg |
| Sponsor | Holy Stone Healthcare Co., Ltd |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
- Diarrhea
- Abdominal Pain
- Headache
- Drug ineffective
- Colitis ulcerative
- Abdominal pain
- Nausea
- Urinary tract infection
- Sinusitis
- Back pain
- Influenza
- Bronchitis
Key clinical trials
- VERDICT: In actiVE Ulcerative Colitis, a RanDomIzed Controlled Trial for Determination of the Optimal Treatment Target (Phase 4)
- Targeting Oxidative Stress in Chronic Beryllium Disease (Phase 1)
- The Efficacy and Tolerability of Bio-enhanced Curcumin (Diferuloylmethane) in the Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis (Phase 3)
- Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission. A European Multi-centre Investigator Blinded Randomized Controlled Study of Pentasa Sachet Comparing One Gram Twice With Two Gram (Phase 3)
- A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis, in Both Acute a (Phase 3)
- A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis (Phase 3)
- Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial) (Phase 4)
- Tolerability of Pentasa® Sachet in Patients With Ulcerative Colitis Under Conditions of Standard Practice in the Czech Republic (N/A)
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:
- Delzicol CI brief — competitive landscape report
- Delzicol updates RSS · CI watch RSS
- Holy Stone Healthcare Co., Ltd portfolio CI
Frequently asked questions about Delzicol
What is Delzicol?
Who makes Delzicol?
Is Delzicol also known as anything else?
What development phase is Delzicol in?
What are the side effects of Delzicol?
Related
- Manufacturer: Holy Stone Healthcare Co., Ltd — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Mesalamine 400 mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing