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AZD0486
AZD0486 is a mTORC1 inhibitor Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Advanced or metastatic solid tumors with mTOR pathway activation. Also known as: TNB-486, Surovatamig.
AZD0486 is a selective inhibitor of the mechanistic target of rapamycin complex 1 (mTORC1) that suppresses protein synthesis and cell proliferation in cancer cells.
AZD0486 is a selective inhibitor of the mechanistic target of rapamycin complex 1 (mTORC1) that suppresses protein synthesis and cell proliferation in cancer cells. Used for Advanced or metastatic solid tumors with mTOR pathway activation.
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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
AstraZeneca 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 | AZD0486 |
|---|---|
| Also known as | TNB-486, Surovatamig |
| Sponsor | AstraZeneca |
| Drug class | mTORC1 inhibitor |
| Target | mTORC1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
AZD0486 binds to and inhibits mTORC1, a key signaling complex that regulates cell growth, metabolism, and survival. By blocking mTORC1 activity, the drug reduces protein synthesis and induces cell cycle arrest, leading to reduced proliferation of cancer cells. This mechanism is particularly relevant in tumors with dysregulated mTOR pathway signaling.
Approved indications
- Advanced or metastatic solid tumors with mTOR pathway activation
Common side effects
- Stomatitis
- Rash
- Diarrhea
- Fatigue
- Hyperglycemia
Key clinical trials
- AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL (PHASE3)
- A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients (PHASE3)
- A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma (PHASE1)
- Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL (PHASE2)
- A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies (PHASE1, PHASE2)
- AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia (PHASE1, 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:
- AZD0486 CI brief — competitive landscape report
- AZD0486 updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about AZD0486
What is AZD0486?
How does AZD0486 work?
What is AZD0486 used for?
Who makes AZD0486?
Is AZD0486 also known as anything else?
What drug class is AZD0486 in?
What development phase is AZD0486 in?
What are the side effects of AZD0486?
What does AZD0486 target?
Related
- Drug class: All mTORC1 inhibitor drugs
- Target: All drugs targeting mTORC1
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic solid tumors with mTOR pathway activation
- Also known as: TNB-486, Surovatamig
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing