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Placebo for relugolix
Placebo for relugolix is a Small molecule drug developed by Myovant Sciences GmbH. It is currently in Phase 3 development.
A placebo control contains no active pharmaceutical ingredient and serves as a comparator in clinical trials to establish the efficacy of relugolix.
Relugolix is a small molecule gonadotropin-releasing hormone receptor antagonist used in clinical trials for conditions such as heavy menstrual bleeding, uterine fibroids, and oligometastatic prostate carcinoma. In a Phase 3 clinical trial (NCT06671548), a placebo of relugolix was used as a control in a study comparing its efficacy and safety to estradiol/norethindrone acetate in women with heavy menstrual bleeding associated with uterine fibroids.
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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).
| 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 | Placebo for relugolix |
|---|---|
| Sponsor | Myovant Sciences GmbH |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Placebos are inert formulations used in randomized controlled trials to provide a baseline against which the active drug's effects can be measured. In Phase 3 trials for relugolix, the placebo arm allows researchers to distinguish genuine therapeutic effects from natural disease progression or placebo response. This is a standard control rather than a therapeutic agent.
Approved indications
Common side effects
Key clinical trials
- Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids (PHASE3)
- Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study (PHASE2)
- Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids (PHASE3)
- LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids (PHASE3)
- LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids (PHASE3)
- SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain (PHASE3)
- SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain (PHASE3)
- A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids (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:
- Placebo for relugolix CI brief — competitive landscape report
- Placebo for relugolix updates RSS · CI watch RSS
- Myovant Sciences GmbH portfolio CI
Frequently asked questions about Placebo for relugolix
What is Placebo for relugolix?
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What development phase is Placebo for relugolix in?
Related
- Manufacturer: Myovant Sciences GmbH — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing