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Micronutrient with zinc
Micronutrient with zinc is a Micronutrient supplement Small molecule drug developed by All India Institute of Medical Sciences. It is currently in Phase 3 development for Zinc deficiency or supplementation in immunocompromised populations, Adjunctive therapy in conditions requiring enhanced immune function or wound healing. Also known as: study drug.
Zinc supplementation supports immune function, wound healing, and protein synthesis by serving as a cofactor for numerous enzymes and proteins involved in cellular immunity and tissue repair.
Zinc is a micronutrient that plays a crucial role in maintaining various bodily functions, and its deficiency has been linked to conditions such as anemia, iron deficiency, and hemoglobin disorders. As a small molecule, zinc functions as a sunscreen and skin protectant, helping to protect the skin from damage.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Micronutrient with zinc |
|---|---|
| Also known as | study drug |
| Sponsor | All India Institute of Medical Sciences |
| Drug class | Micronutrient supplement |
| Target | Zinc-dependent enzymes and metalloproteins |
| Modality | Small molecule |
| Therapeutic area | Immunology, Nutritional deficiency, Wound healing |
| Phase | Phase 3 |
Mechanism of action
Zinc is an essential micronutrient that acts as a cofactor for over 300 enzymes and plays critical roles in immune cell development, antibody production, and inflammatory response regulation. It is particularly important for T-cell function, natural killer cell activity, and maintaining the integrity of mucosal barriers. Zinc deficiency impairs immune responses and delays wound healing, making supplementation therapeutically relevant in conditions characterized by immune dysfunction or impaired tissue repair.
Approved indications
- Zinc deficiency or supplementation in immunocompromised populations
- Adjunctive therapy in conditions requiring enhanced immune function or wound healing
Common side effects
- Nausea
- Gastrointestinal upset
- Metallic taste
- Copper deficiency (with chronic high-dose supplementation)
Key clinical trials
- Child Health, Agriculture and Integrated Nutrition (NA)
- Chemo Brain Prehab Project (NA)
- Nutritional Intervention With Tenebrio Molitor Powder in Children With Chronic Malnutrition in the Democratic Republic of the Congo (NA)
- Probiotic Impact on Cognitive Performance, and Metabolic Outcomes in Overweight Young Adults With Impaired Glucose Regulation (NA)
- Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC) (PHASE1)
- Wide Spectrum Micronutrients Supplementation in Patients With Cancer Related Fatigue During Neoadjuvant and Adjuvant Chemotherapy (NA)
- Micronutrient Dose Response Study in Bangladesh (NA)
- Effect of a Dairy Product for Pregnant and Lactating Women on the Composition of Human Milk (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:
- Micronutrient with zinc CI brief — competitive landscape report
- Micronutrient with zinc updates RSS · CI watch RSS
- All India Institute of Medical Sciences portfolio CI
Frequently asked questions about Micronutrient with zinc
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Related
- Drug class: All Micronutrient supplement drugs
- Target: All drugs targeting Zinc-dependent enzymes and metalloproteins
- Manufacturer: All India Institute of Medical Sciences — full pipeline
- Therapeutic area: All drugs in Immunology, Nutritional deficiency, Wound healing
- Indication: Drugs for Zinc deficiency or supplementation in immunocompromised populations
- Indication: Drugs for Adjunctive therapy in conditions requiring enhanced immune function or wound healing
- Also known as: study drug
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing