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Hydroxychloroquin with Azithromycin
Hydroxychloroquin with Azithromycin is a Small molecule drug developed by Alkarkh Health Directorate-Baghdad. It is currently in Phase 1 development.
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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 | Hydroxychloroquin with Azithromycin |
|---|---|
| Sponsor | Alkarkh Health Directorate-Baghdad |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants (PHASE2)
- Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment (PHASE3)
- Safety and Efficacy of Intravenous Wharton's Jelly Derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Due to COVID 19 (PHASE1, PHASE2)
- Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (PHASE3)
- Hydroxychloroquine,Hydroxychloroquine,Azithromycin in the Treatment of SARS CoV-2 Infection (PHASE3)
- A Study of Quintuple Therapy to Treat COVID-19 Infection (PHASE2)
- Randomised Evaluation of COVID-19 Therapy (PHASE3)
- Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients (PHASE2)
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:
- Hydroxychloroquin with Azithromycin CI brief — competitive landscape report
- Hydroxychloroquin with Azithromycin updates RSS · CI watch RSS
- Alkarkh Health Directorate-Baghdad portfolio CI
Frequently asked questions about Hydroxychloroquin with Azithromycin
What is Hydroxychloroquin with Azithromycin?
Who makes Hydroxychloroquin with Azithromycin?
What development phase is Hydroxychloroquin with Azithromycin in?
Related
- Manufacturer: Alkarkh Health Directorate-Baghdad — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing