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TAP-144-SR(3M)
TAP-144-SR(3M) is a GnRH agonist Small molecule drug developed by Takeda. It is currently in Phase 3 development for Advanced prostate cancer, Endometriosis, Uterine fibroids.
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(3M) is being studied in clinical trials for Prostate Cancer and Premenopausal Breast Cancer. The exact mechanism of TAP-144-SR(3M) is not specified in the provided facts, but it is being compared to TAP-144-SR(6M) in a Phase 3 study for Prostate Cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
Takeda is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | TAP-144-SR(3M) |
|---|---|
| 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 or estrogen reduction, making it effective for hormone-dependent cancers and certain endocrine disorders. The SR (sustained-release) 3-month formulation provides extended drug delivery over a quarterly dosing interval.
Approved indications
- Advanced prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
Common side effects
- Hot flashes
- Injection site reaction
- Decreased libido
- Erectile dysfunction
- Bone density loss
- Fatigue
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(3M) CI brief — competitive landscape report
- TAP-144-SR(3M) updates RSS · CI watch RSS
- Takeda portfolio CI
Frequently asked questions about TAP-144-SR(3M)
What is TAP-144-SR(3M)?
How does TAP-144-SR(3M) work?
What is TAP-144-SR(3M) used for?
Who makes TAP-144-SR(3M)?
What drug class is TAP-144-SR(3M) in?
What development phase is TAP-144-SR(3M) in?
What are the side effects of TAP-144-SR(3M)?
What does TAP-144-SR(3M) target?
Related
- Drug class: All GnRH agonist drugs
- Target: All drugs targeting GnRH receptor
- Manufacturer: Takeda — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced prostate cancer
- Indication: Drugs for Endometriosis
- Indication: Drugs for Uterine fibroids
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing