ACR16

Teva Branded Pharmaceutical Products R&D, Inc. · Phase 3 active Small molecule

ACR16 is a Small molecule drug developed by Teva Branded Pharmaceutical Products R&D, Inc.. It is currently in Phase 3 development. Also known as: Pridopidine, pridopidine.

ACR16 is an investigational therapeutic in phase 3 development by Teva, but its specific mechanism of action is not publicly disclosed.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

• 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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	ACR16
Also known as	Pridopidine, pridopidine
Sponsor	Teva Branded Pharmaceutical Products R&D, Inc.
Modality	Small molecule
Phase	Phase 3

Mechanism of action

Without access to detailed clinical trial data or published mechanism information, the precise molecular target and pharmacological action of ACR16 cannot be reliably determined. Phase 3 status indicates it has progressed beyond early-stage testing, but the mechanism remains proprietary or undisclosed in available sources.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• A Study of Pridopidine (ACR16) for the Treatment of Participants With Huntington's Disease (PHASE2)
• A Study of Treatment With Pridopidine (ACR16) in Participants With Huntington's Disease (PHASE3)
• Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington Disease (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:

• ACR16 CI brief — competitive landscape report
• ACR16 updates RSS · CI watch RSS
• Teva Branded Pharmaceutical Products R&D, Inc. portfolio CI

Frequently asked questions about ACR16

What is ACR16?

ACR16 is a Small molecule drug developed by Teva Branded Pharmaceutical Products R&D, Inc..

How does ACR16 work?

ACR16 is an investigational therapeutic in phase 3 development by Teva, but its specific mechanism of action is not publicly disclosed.

Who makes ACR16?

ACR16 is developed by Teva Branded Pharmaceutical Products R&D, Inc. (see full Teva Branded Pharmaceutical Products R&D, Inc. pipeline at /company/teva-branded-pharmaceutical-products-r-d-inc).

Is ACR16 also known as anything else?

ACR16 is also known as Pridopidine, pridopidine.

What development phase is ACR16 in?

ACR16 is in Phase 3.

Related

• Manufacturer: Teva Branded Pharmaceutical Products R&D, Inc. — full pipeline
• Also known as: Pridopidine, pridopidine