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Neo-Calglucon (CALCIUM GLUBIONATE)

Phase 2 active Small molecule Under review

Neo-Calglucon (generic name: CALCIUM GLUBIONATE) is a calcium glubionate drug. It is currently in Phase 2 development for Hypocalcemia.

Neo-Calglucon works by replenishing calcium stores in the body.

Neo-Calglucon is a small molecule calcium compound used in dental procedures, specifically in pulpotomy treatments for primary teeth. It has been studied in clinical trials for various conditions, including dentin caries and esophageal adenocarcinoma, but its primary use is in dental applications.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • 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).
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameCALCIUM GLUBIONATE
Drug classcalcium glubionate
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Think of calcium like a key that unlocks the doors to your cells, allowing them to function properly. When you have low calcium levels, your cells can't work as well as they should, leading to problems like muscle cramps and weakness. Taking Neo-Calglucon helps to restore the right balance of calcium in your body, so your cells can function normally again.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Neo-Calglucon

What is Neo-Calglucon?

Neo-Calglucon (CALCIUM GLUBIONATE) is a calcium glubionate drug, indicated for Hypocalcemia.

How does Neo-Calglucon work?

Neo-Calglucon works by replenishing calcium stores in the body.

What is Neo-Calglucon used for?

Neo-Calglucon is indicated for Hypocalcemia.

What is the generic name of Neo-Calglucon?

CALCIUM GLUBIONATE is the generic (nonproprietary) name of Neo-Calglucon.

What drug class is Neo-Calglucon in?

Neo-Calglucon belongs to the calcium glubionate class. See all calcium glubionate drugs at /class/calcium-glubionate.

What development phase is Neo-Calglucon in?

Neo-Calglucon is in Phase 2.

What are the side effects of Neo-Calglucon?

Common side effects of Neo-Calglucon include Liver injury, Psoriatic arthropathy, Glossodynia, Pemphigus, Systemic lupus erythematosus, Hand deformity.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing