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Unikalk
Unikalk is a Small molecule drug developed by Erling Bjerregaard Pedersen. It is currently in Phase 2 development.
Unikalk is a treatment that involves vitamin D substitution, specifically cholecalciferol, for patients with chronic pancreatitis and malabsorption syndromes. It may also be used to treat other conditions such as Roux-en-Y gastric bypass, hyperparathyroidism, and hypoparathyroidism post-surgery, although the evidence is based on a single clinical trial.
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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 | Unikalk |
|---|---|
| Sponsor | Erling Bjerregaard Pedersen |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Effects of Total Thyroid Removal on Parathyroid Function and Quality of Life (NA)
- Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass (NA)
- Effect of the Aquaretic Tolvaptan on Nitric Oxide System. A Dose-response Study (DOVA) (PHASE2)
- Effect of the Aquaretic Tolvaptan on Nitric Oxide System (PHASE2)
- The Effects of Atorvastatin on the Nitrogen Oxide-system in Patients With Type 2 Diabetes and Nephropathy (PHASE2)
- The Effects of Atorvastatin on the Nitric Oxide-system in Patients With Non-diabetic Nephropathy (PHASE2)
- Effect of the Aquaretic Tolvaptan on Nitric Oxide System (TORA) (PHASE2)
- Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption (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:
- Unikalk CI brief — competitive landscape report
- Unikalk updates RSS · CI watch RSS
- Erling Bjerregaard Pedersen portfolio CI
Frequently asked questions about Unikalk
What is Unikalk?
Who makes Unikalk?
What development phase is Unikalk in?
Related
- Manufacturer: Erling Bjerregaard Pedersen — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing