Last reviewed · How we verify
Placebo for methotrexate
Placebo for methotrexate is a Small molecule drug developed by Amgen. It is currently in Phase 3 development for Control arm in Phase 3 clinical trial for methotrexate.
A placebo contains no active pharmaceutical ingredient and produces no direct pharmacological effect.
Placebo is used as a control intervention in clinical trials studying the effects of methotrexate on various conditions, including osteoarthritis of the knee, rheumatoid arthritis, and HIV. Methotrexate is a small molecule modality, as classified by ChEMBL, and is being studied in clinical trials, with Placebo serving as a comparison in these studies.
-
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). -
Big-pharma sponsor
+3.0pp
Amgen 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 | Placebo for methotrexate |
|---|---|
| Sponsor | Amgen |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Placebos are inert substances used as controls in clinical trials to establish the efficacy of an active drug by comparison. Any observed effects in placebo groups are attributed to the placebo effect, natural disease progression, or regression to the mean. In this Phase 3 trial context, the placebo serves as the control arm against which methotrexate efficacy is measured.
Approved indications
- Control arm in Phase 3 clinical trial for methotrexate
Common side effects
Key clinical trials
- Local Methotrexate Injections for the Treatment of Nail Psoriasis (PHASE4)
- A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE) (PHASE2)
- Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis (PHASE2)
- CD40L Antagonism in Rheumatoid Arthritis (RA) (PHASE2)
- Combination of Methotrexate and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo (PHASE2)
- Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis (PHASE3)
- Methotrexate in Erosive Inflammatory Hand Osteoarthritis (PHASE4)
- Abatacept as GVHD Prophylaxis Phase 2 (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 |
|---|---|
| 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 methotrexate CI brief — competitive landscape report
- Placebo for methotrexate updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about Placebo for methotrexate
What is Placebo for methotrexate?
How does Placebo for methotrexate work?
What is Placebo for methotrexate used for?
Who makes Placebo for methotrexate?
What development phase is Placebo for methotrexate in?
Related
- Manufacturer: Amgen — full pipeline
- Indication: Drugs for Control arm in Phase 3 clinical trial for methotrexate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing