Last reviewed · How we verify
Vitamin B4 (ADENINE)
Adenine, marketed as Vitamin B4, is positioned in the whole blood collection market with a unique mechanism of action involving the inhibition of Leucine-rich repeat serine/threonine-protein kinase 2. Its key competitive advantage lies in its distinct mechanism of action and the protection of its composition patent until 2028. The primary risk is the presence of off-patent competitors like allopurinol and the upcoming patent expiry of febuxostat in 2031, which may increase market competition.
At a glance
| Generic name | ADENINE |
|---|---|
| Drug class | Calculi Dissolution Agent [EPC] |
| Target | Phosphatidylinositol 4-kinase, PI4K, Leucine-rich repeat serine/threonine-protein kinase 2, Xanthine dehydrogenase/oxidase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2021 |
Approved indications
- Whole Blood Collection
- Blood Component Processing
- Donor Sample Collection
Common side effects
Key clinical trials
- A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) (PHASE3)
- A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) (PHASE3)
- Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men (PHASE2,PHASE3)
- Combination Gerotherapeutic Interventions for Healthspan Improvement (PHASE3)
- Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders (PHASE2)
- Antiviral Clinical Trial for Long Covid-19 (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Vitamin B4 CI brief — competitive landscape report
- Vitamin B4 updates RSS · CI watch RSS