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Placebo ovules
Placebo ovules is a Small molecule drug developed by Lee's Pharmaceutical Limited. It is currently in Phase 3 development for Clinical trial control comparator (indication-dependent on parent trial).
Placebo ovules contain inert ingredients with no active pharmaceutical component and produce therapeutic effects primarily through the placebo effect.
Placebo ovules contain inert ingredients with no active pharmaceutical component and produce therapeutic effects primarily through the placebo effect. Used for Clinical trial control comparator (indication-dependent on parent trial).
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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 ovules |
|---|---|
| Sponsor | Lee's Pharmaceutical Limited |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Placebo ovules are formulated vaginal dosage forms containing no active drug substance. They are used in clinical trials as control comparators to measure the placebo effect and distinguish true drug efficacy from patient expectation and natural disease progression. The therapeutic response observed is attributed to psychological and psychosomatic mechanisms rather than pharmacological action.
Approved indications
- Clinical trial control comparator (indication-dependent on parent trial)
Common side effects
Key clinical trials
- A Clinical Study of INTRAROSA® (Prasterone) Vaginal Inserts in Postmenopausal Vulvovaginal Atrophy (PHASE3)
- Efficacy Evaluation of Pitaya Ovule Extract on Skin (NA)
- EFFICACY AND SAFETY OF OVA AND LAVAGE MEDICAL DEVICES IN THE TREATMENT OF NON-SPECIFIC VULVOVAGINITIS (NA)
- Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain (PHASE3)
- Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer (PHASE3)
- Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess After Laparoscopic Hysterectomy (NA)
- Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause (PHASE3)
- Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies (PHASE4)
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 ovules CI brief — competitive landscape report
- Placebo ovules updates RSS · CI watch RSS
- Lee's Pharmaceutical Limited portfolio CI
Frequently asked questions about Placebo ovules
What is Placebo ovules?
How does Placebo ovules work?
What is Placebo ovules used for?
Who makes Placebo ovules?
What development phase is Placebo ovules in?
Related
- Manufacturer: Lee's Pharmaceutical Limited — full pipeline
- Indication: Drugs for Clinical trial control comparator (indication-dependent on parent trial)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing