Last reviewed 2026-05-31 · How we verify

NUV-1511

Nuvation Bio Inc. · Phase 1 active Small molecule ✓ Verified May 2026

NUV-1511 is a Small molecule drug developed by Nuvation Bio Inc.. It is currently in Phase 1 development.

NUV-1511 is a small molecule being studied in a Phase 1/2 clinical trial for its safety and efficacy in treating various types of advanced solid tumors, including HER2-negative breast cancer, metastatic castration-resistant prostate cancer, pancreatic cancer, platinum-resistant ovarian cancer, and advanced solid tumor. The conditions being studied are listed on ClinicalTrials.gov as Advanced Solid Tumor, HER2-negative Breast Cancer, Metastatic Castration-resistant Prostate Cancer (mCRPC), Pancreatic Cancer, and Platinum-resistant Ovarian Cancer (PROC).

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	NUV-1511
Sponsor	Nuvation Bio Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors (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:

NUV-1511 CI brief — competitive landscape report
NUV-1511 updates RSS · CI watch RSS
Nuvation Bio Inc. portfolio CI

Frequently asked questions about NUV-1511

What is NUV-1511?

NUV-1511 is a Small molecule drug developed by Nuvation Bio Inc..

Who makes NUV-1511?

NUV-1511 is developed by Nuvation Bio Inc. (see full Nuvation Bio Inc. pipeline at /company/nuvation-bio-inc).

What development phase is NUV-1511 in?

NUV-1511 is in Phase 1.

Manufacturer: Nuvation Bio Inc. — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing