AZD2936

AstraZeneca · Phase 2 active Small molecule

AZD2936 is a PI3K delta and PI3K gamma inhibitor Small molecule drug developed by AstraZeneca. It is currently in Phase 2 development for Relapsing multiple sclerosis. Also known as: rilvegostomig, Rilvegostomig.

AZD2936 is a small molecule inhibitor of the PI3K delta and PI3K gamma enzymes.

AZD2936 is a small molecule inhibitor of the PI3K delta and PI3K gamma enzymes. Used for Relapsing multiple sclerosis.

Likelihood of approval

19.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

• Baseline phase 2 → approval rate +15.3pp
  Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
• Immunology slight uplift +1.0pp
  Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
• 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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	AZD2936
Also known as	rilvegostomig, Rilvegostomig
Sponsor	AstraZeneca
Drug class	PI3K delta and PI3K gamma inhibitor
Target	PI3K delta and PI3K gamma
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

By inhibiting these enzymes, AZD2936 reduces the activity of the PI3K/AKT signaling pathway, which is involved in the regulation of immune cell function. This leads to a decrease in the proliferation and survival of immune cells, resulting in anti-inflammatory effects.

Approved indications

• Relapsing multiple sclerosis

Common side effects

• Nasopharyngitis
• Upper respiratory tract infection
• Headache
• Musculoskeletal pain
• Diarrhea
• Nausea
• Vomiting
• Fatigue
• Pyrexia
• Cough

Key clinical trials

• A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC (PHASE3)
• A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC (PHASE1, PHASE2)
• A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies (PHASE1, PHASE2)
• Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) (PHASE2)
• A Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy (PHASE1)
• A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) (PHASE3)
• Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (PHASE3)
• A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (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:

• AZD2936 CI brief — competitive landscape report
• AZD2936 updates RSS · CI watch RSS
• AstraZeneca portfolio CI

Frequently asked questions about AZD2936

What is AZD2936?

AZD2936 is a PI3K delta and PI3K gamma inhibitor drug developed by AstraZeneca, indicated for Relapsing multiple sclerosis.

How does AZD2936 work?

AZD2936 is a small molecule inhibitor of the PI3K delta and PI3K gamma enzymes.

What is AZD2936 used for?

AZD2936 is indicated for Relapsing multiple sclerosis.

Who makes AZD2936?

AZD2936 is developed by AstraZeneca (see full AstraZeneca pipeline at /company/astrazeneca).

Is AZD2936 also known as anything else?

AZD2936 is also known as rilvegostomig, Rilvegostomig.

What drug class is AZD2936 in?

AZD2936 belongs to the PI3K delta and PI3K gamma inhibitor class. See all PI3K delta and PI3K gamma inhibitor drugs at /class/pi3k-delta-and-pi3k-gamma-inhibitor.

What development phase is AZD2936 in?

AZD2936 is in Phase 2.

What are the side effects of AZD2936?

Common side effects of AZD2936 include Nasopharyngitis, Upper respiratory tract infection, Headache, Musculoskeletal pain, Diarrhea, Nausea.

What does AZD2936 target?

AZD2936 targets PI3K delta and PI3K gamma and is a PI3K delta and PI3K gamma inhibitor.

Related

• Drug class: All PI3K delta and PI3K gamma inhibitor drugs
• Target: All drugs targeting PI3K delta and PI3K gamma
• Manufacturer: AstraZeneca — full pipeline
• Therapeutic area: All drugs in Immunology
• Indication: Drugs for Relapsing multiple sclerosis
• Also known as: rilvegostomig, Rilvegostomig