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Bilcolic (HYMECROMONE)
Bilcolic (generic name: HYMECROMONE) is a hymecromone drug. It is currently in Phase 2 development.
Bilcolic works by inhibiting the enzyme carbonic anhydrase 9, which helps regulate fluid and electrolyte balance in the body.
Bilcolic (Hymecromone) is a small molecule drug that targets carbonic anhydrase 9, a key enzyme involved in the regulation of fluid and electrolyte balance. It is classified as a hymecromone, a type of carbonic anhydrase inhibitor. However, there is limited information available on its commercial status, approved indications, and pharmacokinetic properties. Further research is needed to fully understand its clinical applications and safety profile. As a result, its current status in the pharmaceutical market is unclear.
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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). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| 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 | HYMECROMONE |
|---|---|
| Drug class | hymecromone |
| Target | Induced myeloid leukemia cell differentiation protein Mcl-1, Testosterone 17-beta-dehydrogenase 3, Aldose reductase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Think of carbonic anhydrase 9 like a pump that helps move fluid and electrolytes in and out of cells. By blocking this pump, Bilcolic helps reduce swelling and excess fluid in the body. This can be beneficial for people with conditions like edema or glaucoma.
Approved indications
Common side effects
Key clinical trials
- H01 in Adults With Interstitial Lung Disease (The SOLIS Study) (PHASE2)
- Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis. (PHASE2)
- Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease (The SATURN Study). (PHASE2)
- A Safety and Efficacy Study of Hymecromone Tablets for the Treatment of Patients With COVID-19. (NA)
- A Study of Oral Hymecromone and Hyaluronan Synthesis (PHASE1)
- 4-Methylumbelliferone as a Treatment for Chronic HBV/HCV (PHASE2)
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:
- Bilcolic CI brief — competitive landscape report
- Bilcolic updates RSS · CI watch RSS
Frequently asked questions about Bilcolic
What is Bilcolic?
How does Bilcolic work?
What is the generic name of Bilcolic?
What drug class is Bilcolic in?
What development phase is Bilcolic in?
What does Bilcolic target?
Related
- Drug class: All hymecromone drugs
- Target: All drugs targeting Induced myeloid leukemia cell differentiation protein Mcl-1, Testosterone 17-beta-dehydrogenase 3, Aldose reductase
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing