Last reviewed · How we verify
AMG 133
AMG 133 is a Small molecule drug developed by Amgen. It is currently in Phase 1 development. Also known as: Maridebart cafraglutide, maridebart cafraglutide.
AMG 133, also known as Maridebart cafraglutide, is an investigational drug developed by Amgen for the treatment of conditions such as overweight, obesity, and type 2 diabetes mellitus. It is an ICOS ligand inhibitor, classified as an inhibitor drug modality, and is being studied in a Phase 1 clinical trial to assess its bioavailability when administered using two subcutaneous presentations.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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 | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | AMG 133 |
|---|---|
| Also known as | Maridebart cafraglutide, maridebart cafraglutide |
| Sponsor | Amgen |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Nausea
- Vomiting
- Decreased appetite
- Headache
- Abdominal pain
- Gastrooesophageal reflux disease
- Gastroenteritis viral
- Myalgia
- Dizziness
- Conjunctival haemorrhage
- Eye pain
- Abdominal pain upper
Key clinical trials
- Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity (PHASE3)
- A Trial to Compare the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations (PHASE1)
- A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight (PHASE2)
- A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function (PHASE1)
- Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy (PHASE3)
- Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy (PHASE3)
- Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (PHASE3)
- The Effect of AMG 133 on Gastric Emptying (PHASE1)
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:
- AMG 133 CI brief — competitive landscape report
- AMG 133 updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about AMG 133
What is AMG 133?
Who makes AMG 133?
Is AMG 133 also known as anything else?
What development phase is AMG 133 in?
What are the side effects of AMG 133?
Related
- Manufacturer: Amgen — full pipeline
- Also known as: Maridebart cafraglutide, maridebart cafraglutide
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing