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diphenhydramine ampule
diphenhydramine ampule is a Antihistamine Small molecule drug developed by Ministry Of Health / Nineveh Health Directorate. It is currently in Phase 3 development for Relief of allergy symptoms such as itching, redness, and swelling. Also known as: Allermine.
Diphenhydramine acts as an antihistamine by blocking the action of histamine in the body.
Diphenhydramine acts as an antihistamine by blocking the action of histamine in the body. Used for Relief of allergy symptoms such as itching, redness, and swelling.
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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).
| 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 | diphenhydramine ampule |
|---|---|
| Also known as | Allermine |
| Sponsor | Ministry Of Health / Nineveh Health Directorate |
| Drug class | Antihistamine |
| Target | Histamine H1 receptor |
| Modality | Small molecule |
| Therapeutic area | Allergy |
| Phase | Phase 3 |
Mechanism of action
It works by competitively inhibiting the histamine H1 receptor, thereby reducing the symptoms of an allergic reaction. This results in decreased vasodilation, decreased vascular permeability, and decreased smooth muscle contraction.
Approved indications
- Relief of allergy symptoms such as itching, redness, and swelling
Common side effects
- Drowsiness
- Dry mouth
- Dizziness
Key clinical trials
- Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma (PHASE3)
- Role of Nefopam in Rituximab Transfusion Reaction (PHASE3)
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:
- diphenhydramine ampule CI brief — competitive landscape report
- diphenhydramine ampule updates RSS · CI watch RSS
- Ministry Of Health / Nineveh Health Directorate portfolio CI
Frequently asked questions about diphenhydramine ampule
What is diphenhydramine ampule?
How does diphenhydramine ampule work?
What is diphenhydramine ampule used for?
Who makes diphenhydramine ampule?
Is diphenhydramine ampule also known as anything else?
What drug class is diphenhydramine ampule in?
What development phase is diphenhydramine ampule in?
What are the side effects of diphenhydramine ampule?
What does diphenhydramine ampule target?
Related
- Drug class: All Antihistamine drugs
- Target: All drugs targeting Histamine H1 receptor
- Manufacturer: Ministry Of Health / Nineveh Health Directorate — full pipeline
- Therapeutic area: All drugs in Allergy
- Indication: Drugs for Relief of allergy symptoms such as itching, redness, and swelling
- Also known as: Allermine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing