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Dimethindene (dimetindene)
Dimethindene (generic name: dimetindene) is a dimetindene Small molecule drug developed by Margitta Worm. It is currently in Phase 1 development.
Dimethindene works by blocking the histamine H1 receptor, which is involved in allergic reactions and other histamine-related processes.
Dimethindene, also known as dimetindene, is a small molecule drug that targets the histamine H1 receptor. It is developed and owned by Margitta Worm, but its commercial status is unknown. Dimethindene is used to treat histamine-related conditions, although its approved indications are not specified. The drug has a half-life of 4.6 hours, but its bioavailability and generic manufacturing status are unknown. As a result, its availability and pricing are uncertain.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | dimetindene |
|---|---|
| Sponsor | Margitta Worm |
| Drug class | dimetindene |
| Target | Histamine H1 receptor, Muscarinic acetylcholine receptor M1, Muscarinic acetylcholine receptor M2 |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Mechanism of action
Imagine your body has a system to respond to threats, like an allergic reaction. Histamine is a chemical that helps trigger this response. Dimethindene blocks the receptors that histamine binds to, reducing the severity of the allergic reaction.
Approved indications
Common side effects
- Polyneuropathy
- COVID-19
- General physical health deterioration
- Renal pain
- Pyrexia
- Thyroid stimulating immunoglobulin increased
- Leukopenia
- Blood lactate dehydrogenase increased
- Coronavirus infection
- Chronic hepatitis B
- Anti-thyroid antibody positive
- Glomerulonephritis chronic
Key clinical trials
- Steroid Use in Treatment of Allergic Reactions to Food (PHASE4)
- Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu (PHASE3)
- Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers (PHASE1,PHASE2)
- Placebo Effect in the Treatment of Atopic Dermatitis (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:
- Dimethindene CI brief — competitive landscape report
- Dimethindene updates RSS · CI watch RSS
- Margitta Worm portfolio CI
Frequently asked questions about Dimethindene
What is Dimethindene?
How does Dimethindene work?
Who makes Dimethindene?
What is the generic name of Dimethindene?
What drug class is Dimethindene in?
What development phase is Dimethindene in?
What are the side effects of Dimethindene?
What does Dimethindene target?
Related
- Drug class: All dimetindene drugs
- Target: All drugs targeting Histamine H1 receptor, Muscarinic acetylcholine receptor M1, Muscarinic acetylcholine receptor M2
- Manufacturer: Margitta Worm — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing