Last reviewed 2026-05-24 · How we verify

recombinant human alpha B-crystallin

Delta Crystallon BV · Phase 2 active Biologic ✓ Verified May 2026

recombinant human alpha B-crystallin is a Biologic drug developed by Delta Crystallon BV. It is currently in Phase 2 development. Also known as: HspB5; CRYAB; DC-TAB.

Recombinant human alpha B-crystallin is a hydrolytic enzyme that targets hyaluronic acid. It is being studied in clinical trials, including one for multiple sclerosis, to evaluate its safety and efficacy.

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	recombinant human alpha B-crystallin
Also known as	HspB5; CRYAB; DC-TAB
Sponsor	Delta Crystallon BV
Modality	Biologic
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

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:

recombinant human alpha B-crystallin CI brief — competitive landscape report
recombinant human alpha B-crystallin updates RSS · CI watch RSS
Delta Crystallon BV portfolio CI

Frequently asked questions about recombinant human alpha B-crystallin

What is recombinant human alpha B-crystallin?

recombinant human alpha B-crystallin is a Biologic drug developed by Delta Crystallon BV.

Who makes recombinant human alpha B-crystallin?

recombinant human alpha B-crystallin is developed by Delta Crystallon BV (see full Delta Crystallon BV pipeline at /company/delta-crystallon-bv).

Is recombinant human alpha B-crystallin also known as anything else?

recombinant human alpha B-crystallin is also known as HspB5; CRYAB; DC-TAB.

What development phase is recombinant human alpha B-crystallin in?

recombinant human alpha B-crystallin is in Phase 2.

Manufacturer: Delta Crystallon BV — full pipeline
Also known as: HspB5; CRYAB; DC-TAB

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