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Ganite (GALLIUM NITRATE)
Gallium Nitrate (Ganite) is a marketed drug primarily used for its mechanism of chelating calcium ions, which reduces their levels in the blood. The key strength of Ganite lies in its unique mechanism of action, which differentiates it from other treatments in the market. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic versions.
At a glance
| Generic name | GALLIUM NITRATE |
|---|---|
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 1991 |
Approved indications
Common side effects
- Transient hypophosphatemia
- Decreased serum bicarbonate
- Serum phosphorus <1.5 mg/dL
- Serum phosphorus 1.5-2.4 mg/dL
- Adverse renal effects (elevated BUN and creatinine)
- Nausea and/or vomiting
- Tachycardia
- Lethargy
- Confusion
- Diarrhea
- Constipation
- Lower extremity edema
Serious adverse events
- Acute renal failure
- Hypocalcemia
- Acute optic neuritis
- Permanent blindness
- Decreased hearing
- Pleural effusion
- Pulmonary infiltrates
- Encephalopathy
- Coma
- Death
Key clinical trials
- IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study) (PHASE1)
- Gan & Lee Insulin Glargine Target Type (1) Evaluating Research (PHASE3)
- A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients (PHASE1)
- Gan & Lee Insulin Glargine Target Type (2) Evaluating Research (PHASE3)
- PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males (PHASE1)
- PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males (PHASE1)
- Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro (PHASE3)
- PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients (PHASE1)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Ganite CI brief — competitive landscape report
- Ganite updates RSS · CI watch RSS