Last reviewed 2026-05-30 · How we verify

MR-107A-02

Viatris Specialty LLC · Phase 3 active Small molecule Under review

MR-107A-02 is a SGLT2 inhibitor Small molecule drug developed by Viatris Specialty LLC. It is currently in Phase 3 development for Type 2 diabetes.

MR-107A-02 is a small molecule that targets the SGLT2 receptor.

MR-107A-02 is a treatment being studied for post surgical dental pain, acute pain, and pain. It is being compared to a placebo and tramadol in a randomized, double-blind, placebo-controlled study.

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	MR-107A-02
Sponsor	Viatris Specialty LLC
Drug class	SGLT2 inhibitor
Target	SGLT2
Modality	Small molecule
Therapeutic area	Diabetes
Phase	Phase 3

Mechanism of action

By inhibiting SGLT2, MR-107A-02 reduces glucose reabsorption in the kidneys, thereby lowering blood glucose levels. This mechanism is particularly beneficial for patients with type 2 diabetes.

Approved indications

Type 2 diabetes

Common side effects

Nausea
Diarrhea
Vomiting

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:

MR-107A-02 CI brief — competitive landscape report
MR-107A-02 updates RSS · CI watch RSS
Viatris Specialty LLC portfolio CI

Frequently asked questions about MR-107A-02

What is MR-107A-02?

MR-107A-02 is a SGLT2 inhibitor drug developed by Viatris Specialty LLC, indicated for Type 2 diabetes.

How does MR-107A-02 work?

MR-107A-02 is a small molecule that targets the SGLT2 receptor.

What is MR-107A-02 used for?

MR-107A-02 is indicated for Type 2 diabetes.

Who makes MR-107A-02?

MR-107A-02 is developed by Viatris Specialty LLC (see full Viatris Specialty LLC pipeline at /company/viatris-specialty-llc).

What drug class is MR-107A-02 in?

MR-107A-02 belongs to the SGLT2 inhibitor class. See all SGLT2 inhibitor drugs at /class/sglt2-inhibitor.

What development phase is MR-107A-02 in?

MR-107A-02 is in Phase 3.

What are the side effects of MR-107A-02?

Common side effects of MR-107A-02 include Nausea, Diarrhea, Vomiting.

What does MR-107A-02 target?

MR-107A-02 targets SGLT2 and is a SGLT2 inhibitor.

Drug class: All SGLT2 inhibitor drugs
Target: All drugs targeting SGLT2
Manufacturer: Viatris Specialty LLC — full pipeline
Therapeutic area: All drugs in Diabetes
Indication: Drugs for Type 2 diabetes

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