Mira Pharmaceuticals Inc

Mira Pharmaceuticals Inc Advancing innovative oral therapeutics for neuropathic pain, inflammation, metabolic disorders, and oncology-related diseases.

06/19/2026

$MIRA | Advancing Ketamir-2 Toward Phase 2a

MIRA Pharmaceuticals has submitted its Phase 2a clinical study plan to the FDA for Ketamir-2, our investigational therapy being developed for chemotherapy-induced peripheral neuropathy (CIPN).

CIPN affects an estimated 30–40% of patients receiving chemotherapy and can significantly impact quality of life. Despite its prevalence, there are currently no FDA-approved therapies specifically developed for this condition.
Ketamir-2 has completed Phase 1 clinical development with no serious adverse events.

The submission of the Phase 2a study plan represents an important step in the clinical development process as we continue working to address a significant unmet medical need in oncology supportive care.

This post contains forward-looking statements. See our SEC filings for risk factors.

06/16/2026

$MIRA | MIRA Pharmaceuticals will be attending BIO International Convention in San Diego, June 22–25.

Ketamir-2 has successfully completed Phase 1 clinical development and is advancing toward Phase 2a evaluation in chemotherapy-induced peripheral neuropathy (CIPN), an area of significant unmet medical need with no FDA-approved therapies.

Program highlights:
• Once-daily oral administration
• DEA non-scheduled
• Patent-protected across major pharmaceutical markets
• Supported by completed Phase 1 clinical data

MIRA Pharmaceuticals is a NASDAQ-listed biotechnology company with a clean capital structure and is available for licensing, co-development, and strategic partnership discussions.

To schedule a meeting, please submit a request through the BIO Partnering Portal.

06/11/2026

$MIRA Prescribing gabapentin for CIPN is not a treatment decision. It is a concession that no better option exists.

For oncology patients dealing with chemo-induced nerve damage, the pharmacologic fallback is a drug approved for epilepsy and a drug approved for diabetic neuropathy. Neither was tested in CIPN at approval. Neither is FDA-approved for CIPN today. Patients are not getting care tailored to their condition.

They are getting the closest approximation medicine could find. Ketamir-2 is being built specifically for this population, from the ground up, with a mechanism designed for the biology of chemotherapy-induced nerve injury.

$MIRA

06/09/2026

$MIRA | Ketamir-2 Preclinical Data

Scientific findings carry greater weight when they are subjected to independent peer review and published in the scientific literature.

Preclinical data evaluating Ketamir-2 were published in Frontiers in Pharmacology, a peer-reviewed journal, where the compound demonstrated activity in established models of neuropathic pain and was compared against currently available therapies, including gabapentin and pregabalin.

These findings support the continued development of Ketamir-2 as a potential treatment for chemotherapy-induced peripheral neuropathy (CIPN).

Peer-reviewed. Published. Advancing toward the clinic.

$MIRA

06/04/2026

$MIRA | MIRA Pharmaceuticals will be attending the BIO International Convention in San Diego (June 22–25, 2026) and is actively scheduling partnering meetings through the BIO One-on-One Partnering™ portal.

Ketamir-2 continues advancing toward Phase 2a development in chemotherapy-induced peripheral neuropathy (CIPN) following positive Phase 1 clinical results across 56 healthy volunteers.

Ketamir-2 is a proprietary oral NMDA receptor modulator designed with:
• Favorable safety and tolerability
• Dose-proportional PK
• Once-daily oral administration potential
• DEA non-scheduled status

CIPN remains a significant unmet medical need with no FDA-approved therapies currently available.

MIRA believes Ketamir-2’s expanding clinical and intellectual property position may support future strategic licensing, co-development, and broader partnership opportunities.

Partnering meetings are now available through the BIO International partnering platform. Search “MIRA Pharmaceuticals” to request a meeting.

06/02/2026

$MIRA | SKNY-1 Weight Loss Data — What's Different About This One
With weight loss drugs dominating headlines, one question keeps coming up: what about lean muscle mass?
GLP-1 drugs — the current standard — are highly effective at reducing weight, but a growing body of clinical evidence shows they also reduce lean muscle mass, which has real implications for long-term metabolic health.
MIRA Pharmaceuticals' SKNY-1 preclinical data showed something worth noting:

• ~30% body weight reduction at the higher dose
• Reduction in total cholesterol and LDL
• Reduction in liver fat accumulation
• No significant reduction in whole-body density

That fourth point — no lean mass signal — is what makes this dataset worth paying attention to, even at this early preclinical stage.
SKNY-1 is an oral compound working through a completely different mechanism than GLP-1 drugs. More studies are needed before any clinical decisions. But the profile is differentiated — and it's asking the right questions.

📄 Full publication: https://loom.ly/pekcFjA
$MIRA $NASDAQ

06/01/2026

MIRA Pharmaceuticals ($MIRA) Secured Worldwide Rights for Ketamir-2!

Last week, MIRA Pharmaceuticals announced the expansion of its exclusive Ketamir-2 license from North American exclusivity to worldwide rights — now covering patent filings across the United States, Europe, China, Japan, Canada, Australia, India, Israel, Mexico, and South Korea.

Here's why it matters beyond the headline:
1. Ketamir-2 is advancing toward Phase 2a in chemotherapy-induced peripheral neuropathy — an indication affecting an estimated 30–40% of chemotherapy patients for which there are currently no FDA-approved treatments. The first approved therapy in CIPN doesn't enter a competitive market. It creates one.
2. Worldwide IP rights mean that commercial opportunity — and any future licensing, co-development, or partnership discussion around it — is now backed by a global patent footprint spanning the world's largest pharmaceutical markets.
3. Phase 1 is complete. 56 healthy volunteers. Zero serious adverse events. Adverse events were higher in the placebo group than in the Ketamir-2-treated group.

Phase 2a protocol submission to the FDA is on deck.
📋 Full PR: https://loom.ly/voWAiIc

$MIRA |

05/28/2026

$MIRA | MIRA Pharmaceuticals — Positive Phase 1 Results for Ketamir-2
MIRA Pharmaceuticals today reported positive unblinded Phase 1 clinical results for Ketamir-2, its oral drug candidate for chemotherapy-induced peripheral neuropathy (CIPN) — nerve damage caused by cancer treatment that affects 30–40% of chemotherapy patients and has zero FDA-approved treatments.

Here's what Phase 1 showed across 56 healthy volunteers:

Safety & Tolerability
• Zero serious adverse events
• Zero dose-limiting toxicities
• Zero withdrawals — all participants completed the study
• Adverse events were predominantly mild — and the incidence was higher in the placebo group than in the Ketamir-2-treated group

Phase 2a in CIPN patients is the next step — submitting the protocol to the FDA under an active IND.
For the millions of cancer patients dealing with lasting nerve damage from chemotherapy and no approved treatment options, this is a program worth watching.

📋 Full PR: https://loom.ly/ZmjC1ME
$MIRA $NASDAQ

05/26/2026

$MIRA | MIRA Pharmaceuticals — Peer-Reviewed Publication for SKNY-1
MIRA Pharmaceuticals today announced that preclinical data for SKNY-1 — its oral drug candidate for obesity and ni****ne addiction — has been published in the International Journal of Molecular Sciences.

• ~30% dose-dependent body weight reduction over six days of oral administration
• Reductions in total cholesterol, LDL, and hepatic triglyceride accumulation
• Attenuation of compulsive feeding and ni****ne-seeking behaviors across multiple behavioral paradigms
• Normalization of appetite-regulatory leptin and ghrelin gene expression toward wild-type levels
• No significant reduction in whole-body density — relevant to the growing clinical focus on lean mass preservation during weight loss treatment

What makes SKNY-1 different: it targets both the metabolic side of obesity and the behavioral side — cravings, compulsive eating, addiction — in one oral compound.
This is early-stage science with more studies ahead, but peer-reviewed publication is an important step.
📄 Full publication: https://loom.ly/pekcFjA
📋 Full PR: https://loom.ly/ArA-uAE
$MIRA $NASDAQ

05/05/2026

Three programs. One team. Each one addressing a condition where patients have been waiting too long.

Ketamir-2 leads the pipeline in CIPN with an established safety profile. SKNY-1 targets weight loss and ni****ne addiction, engineered to avoid the CNS side effects that buried prior CB1 antagonists. MIRA-55 is an oral small molecule that has showcased comparable pain reversal to injected morphine in preclinical inflammatory pain models.

Pipeline breadth at this stage is how you protect against single-asset binary risk while building long-term enterprise value.

We invite you to follow along as we progress all three programs!

#$MIRA

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