RE104 for Lactation

Overseen By Mark Pollack, Chief Medical Officer, M.D.

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Reunion Neuroscience Inc

Must not be taking: Prohibited medications

Disqualifiers: Mastitis, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Single dose

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how quickly the drug RE104 (an experimental treatment) clears from breastmilk after a single injection. The primary goal is to establish when it is safe for mothers to resume breastfeeding after taking this medication. The trial seeks women who have been breastfeeding or pumping for at least four weeks and are willing to temporarily stop breastfeeding while participating. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it mentions that the use of prohibited medications is not allowed. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that RE104 for Injection is likely to be safe for humans?

Research has shown that RE104 for Injection is generally safe for people. In previous studies, participants who took a 30 mg dose experienced some mild side effects, such as nausea, a faster heartbeat without symptoms, headaches, and restlessness. Importantly, no serious health problems occurred. Consistently, studies have found that RE104 is safe enough for further testing in people under medical supervision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for lactation issues, which often focus on hormonal therapies or lifestyle adjustments, RE104 introduces a novel approach by using a unique active ingredient administered via a single subcutaneous injection. Researchers are excited about RE104 because it potentially offers a quicker and less invasive way to support lactation. This new delivery method might also mean fewer side effects and a more rapid onset of action compared to traditional therapies, making it an appealing option for new mothers seeking effective solutions.

What evidence suggests that RE104 for Injection might be an effective treatment for lactation?

Research has shown that RE104 for Injection, which participants in this trial will receive, may help treat postpartum depression. In an earlier study, participants experienced a 23-point drop in depression symptoms after just one 30 mg dose. This suggests that RE104 might quickly ease depression symptoms. Early results also indicate little risk to babies from breastmilk after treatment, suggesting that breastfeeding might be safe soon after. These positive findings make RE104 a promising option for managing postpartum depression. ^{1 3 6 7 8}

Who Is on the Research Team?

Mark Pollack, Chief Medical Officer

Principal Investigator

Reunion Neurosciences Inc

Are You a Good Fit for This Trial?

Healthy breastfeeding women, aged 18-45, who've been nursing or pumping for at least 4 weeks postpartum. Participants must weigh at least 50 kg with a BMI of 18-34 kg/m2, not be pregnant nor planning to become so during the study. They must stop breastfeeding for two weeks and confirm their infant can bottle-feed.

Inclusion Criteria

I am willing and able to pump breast milk for the study.

I have been breastfeeding or pumping for at least 4 weeks after having a full-term pregnancy.

I agree to stop breastfeeding and confirm my baby can bottle-feed during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single subcutaneous injection of 30 mg RE104

Single dose

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days

What Are the Treatments Tested in This Trial?

Interventions

• RE104 for Injection

Trial Overview The trial is studying RE104 for Injection in lactating mothers to see how long it takes for the drug and its byproducts to clear from breastmilk. This will help determine when it's safe to resume breastfeeding after receiving this single-dose injection.

How Is the Trial Designed?

Group I: 30 mg RE104 Experimental Treatment 1 Intervention

A single subcutaneous injection of 30 mg RE104 for Injection

Who Is Running the Clinical Trial?

Reunion Neuroscience Inc

Lead Sponsor

Trials

2

Recruited

90+

Published Research Related to This Trial

Injectable microspheres containing a neurotensin analogue (NA) were successfully created using a novel oil-in-water solvent evaporation method, which effectively entrapped the hydrophilic drug NA.

Optimal conditions for successful entrapment included using an alkaline water phase, adding fatty acid salt to the oily phase, and incorporating a water-miscible solvent, achieving complete entrapment at specific polymer-to-drug ratios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation of neurotensin analogue-containing poly(dl-lactic acid) microspheres formed by oil-in-water solvent evaporation. Yamakawa, I., Tsushima, Y., Machida, R., et al.[2019]

The long-acting injectable microcapsule system for progesterone (P4) provides a controlled release of 1.3 micrograms of P4 per day for up to 30 days, demonstrating a potential for monthly contraceptive use.

In both rats and baboons, a single injection of the P4 microcapsules effectively inhibited vaginal estrous cycles and cyclic ovarian function for one month, indicating its efficacy in reproductive control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new long-acting injectable microcapsule system for the administration of progesterone. Beck, LR., Cowsar, DR., Lewis, DH., et al.[2019]

Retinyl acetate (RA) was successfully encapsulated in PLGA microspheres using supercritical emulsion extraction (SEE), resulting in spherical and free-flowing microspheres with high encapsulation efficiency of 80%-90%.

The continuous operation layout (SEE-C) allowed for better recovery and efficiency, producing microspheres with a mean size of 3.3 to 4.5 μm, and demonstrated a rapid drug release profile, with almost all RA released within 6 days at lower concentrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PLGA microdevices for retinoids sustained release produced by supercritical emulsion extraction: continuous versus batch operation layouts. Porta, GD., Campardelli, R., Falco, N., et al.[2020]

A pharmacokinetic model for the depot formulation depo-subQ provera 104™ was developed and validated using data from three clinical trials, demonstrating its ability to predict key drug absorption parameters like Cmax and Tmax.

The study highlighted that the drug release profile is influenced by factors such as the injection site and patient population, emphasizing the importance of these variables in optimizing therapeutic efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sensitive in vitro performance assay reveals the in vivo drug release mechanisms of long-acting medroxyprogesterone acetate microparticles. Gao, GF., Thurn, M., Wendt, B., et al.[2021]

The study demonstrated that octreotide acetate, delivered via biodegradable PLGA microspheres, exhibits a two-phase drug release profile, with an initial peak in serum levels occurring within 30 minutes, followed by a sustained release phase lasting up to 42 days.

Pharmacokinetic simulations suggest that the Oakwood formulations could maintain steady-state serum levels of octreotide comparable to the established Sandostatin LAR(®) formulation, indicating potential for effective long-term treatment with less frequent dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained-release delivery of octreotide from biodegradable polymeric microspheres. Rhee, YS., Sohn, M., Woo, BH., et al.[2021]

Citations

1. reunionneuro.com reunionneuro.com/2025/08/18/reunion-neuroscience-announces-positive-topline-results-from-reconnect-phase-2-clinical-trial-of-re104-for-the-treatment-of-postpartum-depression-ppd/

Achieved Primary Endpoint with 30mg Dose of RE104 ... Achieved Primary Endpoint with 30mg Dose of RE104 Demonstrating 23.0-Point Reduction from Baseline in Montgomery-Åsberg Depression Rating ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06342310

RE104 Safety and Efficacy Study in Postpartum Depression The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to- ...

3. globenewswire.com globenewswire.com/news-release/2025/08/18/3134924/0/en/Reunion-Neuroscience-Announces-Positive-Topline-Results-from-RECONNECT-Phase-2-Clinical-Trial-of-RE104-for-the-Treatment-of-Postpartum-Depression-PPD.html

Reunion Neuroscience Announces Positive Topline Results -- Preliminary Data from Lactation Study Suggests Mothers Could Return to Breastfeeding Rapidly Following RE104 Treatment --. -- Company ...

4. hcplive.com hcplive.com/view/re104-reduces-postpartum-depression-symptoms-by-day-7-in-phase-2-reconnect

RE104 Reduces Postpartum Depression Symptoms by ... Preliminary data suggest minimal risk to infants from breastmilk metabolites, supporting safe breastfeeding post-treatment.

5. psychiatrictimes.com psychiatrictimes.com/view/re104-a-novel-fast-acting-psychedelic-for-postpartum-depression

RE104: A Novel, Fast-Acting Psychedelic for Postpartum ... A clinical lactation study conducted in 14 healthy lactating women found that zuranolone administered at a dose of 30 mg for 5 days was excreted ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12379775/

Safety, Tolerability, Pharmacokinetics, and ... - PubMed Central RE104 at 30 mg is currently being evaluated for efficacy and safety when administered under health care provider supervision in patients with ...

7. obgyn.mhmedical.com obgyn.mhmedical.com/updatesContent.aspx?gbosId=648623

Reunion Neuroscience: Psychedelic Prodrug RE104 For The ... In general, RE104 was safe and well tolerated by all study participants. Nausea, asymptomatic sinus tachycardia, headache, and restlessness were the most ...

8. psychiatrist.com psychiatrist.com/news/reunions-novel-therapy-shows-promise-for-postpartum-depression/

Reunion's Novel Therapy Shows Promise for Postpartum ... The safety data the study produced appeared to be just as encouraging. The researchers noted that RE104 was generally well tolerated, with ...