Last reviewed 2026-05-28 · How we verify

XOMA 358 multiple dose level 1

XOMA (US) LLC · Phase 2 active Small molecule ✓ Verified May 2026 Quality 0/100

XOMA 358 multiple dose level 1 is a Small molecule drug developed by XOMA (US) LLC. It is currently in Phase 2 development.

XOMA 358 is being studied in an open-label trial for the treatment of hypoglycemia in patients after gastric bypass surgery. The trial involves multiple dose levels of XOMA 358, including single dose levels A, B, and C, but the specific details of these levels are not specified.

Likelihood of approval

15.3% 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).

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	XOMA 358 multiple dose level 1
Sponsor	XOMA (US) LLC
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery (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:

XOMA 358 multiple dose level 1 CI brief — competitive landscape report
XOMA 358 multiple dose level 1 updates RSS · CI watch RSS
XOMA (US) LLC portfolio CI

Frequently asked questions about XOMA 358 multiple dose level 1

What is XOMA 358 multiple dose level 1?

XOMA 358 multiple dose level 1 is a Small molecule drug developed by XOMA (US) LLC.

Who makes XOMA 358 multiple dose level 1?

XOMA 358 multiple dose level 1 is developed by XOMA (US) LLC (see full XOMA (US) LLC pipeline at /company/xoma-us-llc).

What development phase is XOMA 358 multiple dose level 1 in?

XOMA 358 multiple dose level 1 is in Phase 2.

Manufacturer: XOMA (US) LLC — full pipeline

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