Last reviewed · How we verify
Siklos
At a glance
| Generic name | Siklos |
|---|---|
| Also known as | hydroxyurea, hydrocarbamide |
| Sponsor | Theravia |
| Target | Carbonic anhydrase 2, Carbonic anhydrase 5A, mitochondrial, Carbonic anhydrase 9 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Chronic myeloid leukemia
- Hb SS disease
- Hemoglobin SS disease with crisis
- Malignant melanoma
- Malignant tumor of head and/or neck
- Malignant tumor of ovary
- Sickling disorder due to hemoglobin S
Common side effects
- Infections
- Blood and lymphatic system disorders
- Other Infections
- Neutropenia
- Bacterial infections
- Thrombocytopenia
- Viral infections
- Anemia
- Parvovirus B19
- Headache
- Dry skin
- Skin depigmentation/melanonychia
Serious adverse events
- Infections
- Nervous system disorders
- Blood and lymphatic system disorders
- Serious neutropenia
- Gastrointestinal disorders
- Thrombocytopenia
- Anemia
- Fever
- Headache
- Respiratory, thoracic and mediastinal disorders
Key clinical trials
- SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial) (PHASE2)
- Hydroxyurea Therapy for Neurological and Cognitive Protection in Pediatric Sickle Cell Anemia in Uganda ( BRAINSAFE-II ) (PHASE3)
- Optimizing the Management of Sickle Cell Patients on Hydroxyurea: The Value of Therapeutic Pharmacological Monitoring (NA)
- ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension Study
- Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH) (PHASE4)
- A Bioequivalence Study to Compare the Pharmacokinetics of Two Formulations of Siklos® in Healthy Volunteers (PHASE1)
- Novel Dose Escalation to Predict Treatment With Hydroxyurea (EARLY_PHASE1)
- European Sickle Cell Disease Cohort - Hydroxyurea
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:
- Siklos CI brief — competitive landscape report
- Siklos updates RSS · CI watch RSS
- Theravia portfolio CI