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Haloperidol Tablets, Cycle Pharmaceuticals Ltd
Haloperidol Tablets, Cycle Pharmaceuticals Ltd is a Small molecule drug developed by Cycle Pharmaceuticals Ltd.. It is currently in Phase 1 development. Also known as: Benztropine Mesylate Tablets.
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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 | Haloperidol Tablets, Cycle Pharmaceuticals Ltd |
|---|---|
| Also known as | Benztropine Mesylate Tablets |
| Sponsor | Cycle Pharmaceuticals Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fasting Conditions (PHASE1)
- Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fed Conditions (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 |
|---|---|
| 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:
- Haloperidol Tablets, Cycle Pharmaceuticals Ltd CI brief — competitive landscape report
- Haloperidol Tablets, Cycle Pharmaceuticals Ltd updates RSS · CI watch RSS
- Cycle Pharmaceuticals Ltd. portfolio CI
Frequently asked questions about Haloperidol Tablets, Cycle Pharmaceuticals Ltd
What is Haloperidol Tablets, Cycle Pharmaceuticals Ltd?
Who makes Haloperidol Tablets, Cycle Pharmaceuticals Ltd?
Is Haloperidol Tablets, Cycle Pharmaceuticals Ltd also known as anything else?
What development phase is Haloperidol Tablets, Cycle Pharmaceuticals Ltd in?
Related
- Manufacturer: Cycle Pharmaceuticals Ltd. — full pipeline
- Also known as: Benztropine Mesylate Tablets
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing