Inclusion Criteria:

• Participant, participant’s parent, guardian, or LAR must provide signature of informed consent/assent, and once capable (per institution guidelines), there must be documentation of consent/assent by the participant demonstrating they are willing and aware of the investigational nature of the study and related procedures.
• Male or females 12 years of age and older at the time of the first dose of IP.
• Convulsive or nonconvulsive Status Epilepticus (SE) without a pattern toward improvement and at least 15 minutes of continuous or cumulative, intermittent seizure activity in the 30-minute period immediately prior to IP initiation, and either:  Convulsive SE: Clinical seizure activity or Nonconvulsive SE.
• Participants must have received a benzodiazepine and two or more of the following second-line AEDs for treatment of the current episode of SE, administered at an adequate dose and duration to demonstrate efficacy, in the opinion of the investigator.
• BMI < 35 or, if BMI is not able to be calculated at screening, participant is assessed by investigator as not morbidly obese.

Exclusion Criteria:

• Life expectancy of less than 24 hours.
• Anoxic brain injury or an uncontrolled metabolic condition as the primary cause of SE (e.g., hypoglycemia < 50 mg/dL or hyperglycemia > 400 mg/dL).
• Treatment of the current SE episode with IV anesthetics (e.g., midazolam, propofol, thiopental, pentobarbital/phenobarbital or ketamine) at adequate doses and for an adequate duration to induce anesthesia.
• IV anesthesia is medically contraindicated.
• Participants with an advanced directive that would not allow the institution to administer their standard-of-care (SOC) for the treatment of SE.
• Participants known or suspected to be pregnant.
• Participants with known allergy or sensitivity to progesterone or allopregnanolone medications/supplements.
• Receiving a concomitant IV product containing Captisol.
• Known or suspected hepatic insufficiency or hepatic failure.
• Known or suspected stage 3B (moderate to severe; eGFR 44-30), stage 4 (severe; eGFR 29-15), or stage 5 (kidney failure; eGFR < 15 or dialysis) kidney disease
• Use of an investigational product for which less than 30 days or 5 half-lives, whichever is greater, have elapsed from the final product administration.
• Known or suspected history or evidence of a medical condition that, in the investigator’s judgment, would expose participant to an undue risk of a significant adverse event or interfere with assessments of safety or effectiveness during the study.