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TAP-144-SR(6M)
TAP-144-SR is a sustained-release formulation of leuprolide, a GnRH agonist that suppresses luteinizing hormone and follicle-stimulating hormone to reduce sex hormone production.
TAP-144-SR is a sustained-release formulation of leuprolide, a GnRH agonist that suppresses luteinizing hormone and follicle-stimulating hormone to reduce sex hormone production. Used for Advanced prostate cancer, Endometriosis, Uterine fibroids.
At a glance
| Generic name | TAP-144-SR(6M) |
|---|---|
| Sponsor | Takeda |
| Drug class | GnRH agonist |
| Target | GnRH receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Leuprolide works by binding to GnRH receptors in the pituitary gland, initially causing a surge in LH and FSH (flare effect) followed by sustained suppression of these hormones. This leads to castration-level testosterone suppression in males and estrogen suppression in females. The SR(6M) designation indicates a 6-month sustained-release depot formulation designed for prolonged hormone suppression with less frequent dosing.
Approved indications
- Advanced prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
Common side effects
- Hot flashes
- Injection site reaction
- Decreased libido
- Erectile dysfunction
- Headache
- Fatigue
- Bone density loss
Key clinical trials
- A Phase 3 Comparative Study of TAP-144-SR(6M) in Postoperative and Hormone Therapy-naïve Patients With Premenopausal Breast Cancer (PHASE3)
- A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal Therapy (PHASE3)
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:
- TAP-144-SR(6M) CI brief — competitive landscape report
- TAP-144-SR(6M) updates RSS · CI watch RSS
- Takeda portfolio CI