PT00114_Dosage, benefits & legal status
Also known as PT-00114, PT 00114, TCAP-1, TCAP-1 analog, teneurin C-terminal associated peptide-1
An injected peptide derived from TCAP-1, the tail end of the brain protein teneurin-1, aimed at anxiety through latrophilin receptors rather than the stress receptor other drugs block. Phase 1 is finished, and every result so far comes from company press releases.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is PT00114?
Plain language first. The technical label stays, but it never stands alone.Overview
People look it up as a stress and anxiety peptide, so the first thing to know is that no result from it has ever been published. Thirty healthy volunteers took single doses of 125 to 1,000 micrograms under the skin in 5 cohorts, and a repeat-dose study of 24 planned volunteers ran at one German site from August 1 to September 24, 2025; the company reported no serious side effects, with no counts, no pharmacokinetics and no paper. Nobody with anxiety, depression or PTSD has received it. Its sponsor held $565,985 in cash at June 30, 2026 under a going-concern warning, and now expects a first patient dose in the first half of 2027.
PT00114 is Protagenic Therapeutics' clinical candidate derived from TCAP-1, the 41-residue C-terminal peptide of teneurin-1. The company says it acts on the adhesion receptors latrophilin-1 and latrophilin-3 on neurons in the extended amygdala, and that through them it counteracts corticotropin-releasing factor without blocking CRF receptors, the distinction it draws from the CRF1 antagonists that failed repeatedly in anxiety and depression. Its own structure has never been disclosed: the Form 10-K for the year ended March 31, 2026 calls it a 41-residue peptide synthetic TCAP-1 and an L-isomer, while the corporate website calls it a first-in-class synthetic analog of TCAP, and those are not the same claim.
What it's used for
Nothing yet. It has only been given to healthy volunteers in a phase 1 safety study, and it is not sold anywhere; Protagenic is aiming it at generalized anxiety disorder.
How does PT00114 work?
What it does in the body, and where.PT00114 comes from the tail end of a large brain protein, and it aims at a receptor pair unrelated to the stress receptor that other anxiety drugs have tried to block.
- 01A peptide cut from a bigger proteinTeneurin-1 is a 2,725-residue protein anchored in neuron membranes. The 41 residues just before its final GRR signal are released as TCAP-1, teneurin C-terminal associated peptide-1, a signaling peptide with an amidated end. Protagenic licensed the underlying technology from the University of Toronto and took PT00114 into the clinic; it calls PT00114 a synthetic TCAP-1 but has never published that molecule's sequence.
- 02Latrophilin receptors, not CRF receptorsThe company says TCAP-1 binds latrophilin-1 and latrophilin-3, two adhesion G-protein-coupled receptors, on neurons in the extended amygdala, and that through them it counteracts corticotropin-releasing factor and possibly vasopressin without blocking CRF receptors directly. That distinction carries the whole program, because drugs built to block CRF1 receptors failed repeatedly in anxiety and depression. No binding affinity or potency figure for PT00114 at either receptor has been published.
- 03What that did in animalsIn rodent models of anxiety, chronic stress, social defeat and morphine withdrawal, the company's PTSD patent reports a dampened stress response to TCAP-1 at 10 to 250 nanomoles per kilogram. The company says the effect outlasts the peptide's clearance from plasma and uses that to argue for infrequent dosing. Cortisol was used as a biomarker of response in the phase 1, and no human readout from it has been published.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
Single-dose part, 30 volunteers
Investigational- human-early5 sequential cohorts, 30 healthy volunteers, 125 to 1,000 micrograms under the skin, first dosed September 26, 2023 with topline on May 22, 2024. The company reported zero clinically relevant adverse events.
- human-earlyCohort 1 at 125 micrograms was followed for 30 days with no reported adverse reactions; cohort 3 at 500 micrograms reported none in the week after dosing.
- No dataThis part appears in no public trial registry, no pharmacokinetic result has been released, and the wording moved from zero adverse reactions in February 2024 to zero clinically relevant adverse events in May 2024.
Repeat-dose part, one German site
Investigational- human-earlyRandomized, placebo-controlled and double-blind in healthy volunteers at Nuvisan GmbH in Neu-Ulm, Germany, 24 planned, running from August 1 to September 24, 2025 under EU registration 2024-519316-13-00.
- human-earlyThe December 9, 2025 topline says it was well tolerated across all dose ranges, with expected injection-site reactions, no serious adverse events and all cohorts completing dosing. No enrollment figure, dose level, schedule or pharmacokinetic result was given, and the registry record carries no results.
- No dataThe executive chairman said several participants reported an improved sense of well-being and called it anecdotal at this stage. It was unquantified, not blinded as reported and not compared with placebo.
Animal work behind the program
Early research- Animal studyThe company's PTSD patent reports TCAP-1 in rats at 25 nanomoles per kilogram weekly for 3 months and 10 nanomoles per kilogram in a restraint-stress model, 250 nanomoles per kilogram under the skin in a mouse morphine-withdrawal model, and daily dosing under the skin for 7 days in a mouse social-defeat model.
- No dataThe patent's materials section gives 10 nanomoles per kilogram where its first example gives 25, an inconsistency inside the same document.
- No dataThe published behavioral work is on TCAP-1 rather than PT00114, and includes a 2011 report from the originating laboratory in the British Journal of Pharmacology. No peer-reviewed paper on PT00114 itself exists, and the corporate website links no scientific publications at all.
What the filings say about the program
Investigational- RegulatoryBoth human parts ran outside the United States and not under a US investigational new drug application. There is no ClinicalTrials.gov record and no Australian registry entry.
- No dataThe filings describe a phase 1/2a design that would have included patients with depression, generalized anxiety disorder, PTSD or opioid use disorder and up to 28 days of exposure. The registry record and the August 2026 release both describe healthy volunteers, and no patient cohort was ever dosed.
- No dataPhase 2 timing moved from the first quarter of 2026, to early 2026, to late 2026, and then to a fresh three-part phase 1 with a first patient dosed in the first half of 2027.
The sponsor's position
Investigational- RegulatoryCash in the bank fell from $1,509,178 at March 31, 2026 to $565,985 at June 30, 2026. Research spending for that quarter was $109,925 against $394,112 a year earlier.
- No dataThe June 30, 2026 quarterly report says the company does not have sufficient resources to fund its operations past twelve months, and that this raises substantial doubt about its ability to continue as a going concern.
- RegulatoryThe Form 10-K says the stock has been delisted from Nasdaq and now trades only in the over-the-counter market, and the 10-Q cover page lists it on OTCQB; the company's website reports a move from OTC Pink to OTCQB on March 10, 2026. Its auditor changed in August 2025, and the previous auditor's 2024 report carried a going-concern paragraph.
Searches for PT00114 surface PT-141, bremelanotide, a different compound covered separately on this site; the two are unrelated, and the code is also written PT-00114, PT 00114 and, in at least one database, PT100114. TCAP here means teneurin C-terminal associated peptide; the human gene TCAP codes for telethonin, a muscle protein, and has nothing to do with it. The sequence printed for this compound is really the parent peptide's: Protagenic has never disclosed PT00114's structure, and the TCAP-1 version that circulates online, beginning QLLSTGRVQ and ending in a glycine, is off by one residue at each end from the patent's QQLLSTGRVQGYDGYFVLSVEQYLELSDSANNIHFMRQSEI and from the teneurin-1 protein sequence. It is reported that no trial registry identifier could be confirmed; one exists, the European Union record 2024-519316-13-00 for the repeat-dose part, and it is the earlier single-dose part that has no registry entry anywhere. Zero adverse events is quoted for the whole program, but it describes the single-dose part only; the repeat-dose part reported injection-site reactions. The phase 1/2a design in patients with treatment-resistant depression and PTSD is quoted as though it happened, and no patient has been dosed. The improved sense of well-being that gets passed along as evidence of benefit was an unquantified remark the executive chairman himself called anecdotal. It is also described as a corticotropin-releasing hormone inhibitor; by the company's own account it works through latrophilins and does not block CRF receptors. Charles River is sometimes listed as a co-developer, when it and Porsolt were preclinical contract laboratories. First-in-class is the company's own phrase, not a regulatory designation.
The published record
Papers and trials about PT00114
9 papers tagged human · 3 not reviews or lab · 0 clinical trial publications
Furthest stage reached: No clinical trial on record
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about PT00114
Evidence
Investigational
Category
Brain, mood and sleep
Common vial
Varies
Half-life
Not established
How much, and do you cycle it?
The range, and whether you take breaks.125 to 1,000 mcg per dose (phase 1 single-dose part), once in the single-dose part. No schedule published Trial dose
The single-dose part gave one injection per volunteer. The repeat-dose part used an undisclosed schedule over an undisclosed number of days, and the company has published neither.
Not establishedNo figure
No pharmacokinetic data have been released: no half-life, peak time, exposure, bioavailability or clearance route. The phase 1 was designed to measure them, and in December 2025 the company said it was still finalizing pharmacokinetic modeling to support dose selection; nothing has appeared since. It says the effect of TCAP-1 in animals outlasts clearance from plasma, a characterization of animal data rather than a human finding.
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How do I dose and price it?
Enter your vial and your dose. Pick a mix. We show the draw and the cost.The vial holds a fixed amount of drug. Adding more water does not make more drug, it just spreads it thinner, so you draw a bigger number on the syringe for the same dose.
Choose your mix
Measuring the water1 mL = one full 100-unit syringe.
How do you store it?
Before mixing, and after.Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.
Unmixed lyophilized PT00114 keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.
What are the side effects and cautions?
Known cautions and warnings for this compound.Who should avoid it
- Not studied in anyone with an anxiety disorder, depression or PTSD: both parts of the phase 1 enrolled healthy volunteers only
- Not studied in children: the registered study covered adults from 18 years up
- Not studied in pregnancy or breastfeeding, and no reproductive data have been published
- Not studied with any other medicine, and no interaction data exist
Stop and get help
- Swelling, spreading redness or pain at an injection site that does not settle
- Hives, swelling of the face or throat, or trouble breathing after an injection
Common effects
- Across 5 single-dose cohorts of 30 healthy volunteers at 125 to 1,000 micrograms, the company reported zero clinically relevant adverse events
- Cohort 1 at 125 micrograms: no reported adverse reactions, no injection-site reactions and no tolerability problems over a 30-day observation period
- The repeat-dose part reported injection-site reactions described as expected for an injected peptide, no serious adverse events, and all participants completing their dosing schedules
- No adverse-event table, rate or placebo comparison has been published for either part, and no results have been posted to the trial registry
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is PT00114 approved?
And where the numbers on this page come from.No. PT00114 is not approved anywhere and is currently in company-run clinical trials. There is no legal route to obtain it outside a trial.
- Approval statusInvestigational
- RouteUnder the skin (subcutaneous)
- Checked21 October 2026
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesProtagenic Form 10-K, year ended March 31, 2026Protagenic Form 10-Q, quarter ended June 30, 2026Protagenic Form 8-K exhibit 99.1, August 20, 2026Protagenic Form 8-K exhibit 99.1, May 22, 2024Protagenic Form 8-K, filed August 22, 2025Protagenic Form 10-K, filed March 31, 2025EU clinical trial record 2024-519316-13-00 (CTIS data via ctis.eu)Protagenic press release, December 9, 2025Protagenic press release, March 27, 2024Protagenic press release, February 13, 2024US 11,426,444 B2, PTSD use patent (Google Patents)UniProt Q9UKZ4, human teneurin-1FDA GSRS substance search for PT00114Protagenic corporate website
What has happened recently
Not approved anywhere, and no orphan, fast track or breakthrough designation has been reported. The underlying technology was licensed from the University of Toronto under an agreement dated July 31, 2005 and amended February 18, 2015, carrying a 2.5% royalty on net sales, 10% of upfront sublicense fees and 2.5% of sublicensee net sales. First human dosing was on September 26, 2023, in a single-ascending-dose study that appears in no public registry; the repeat-dose part was authorized in the European Union as CTIS 2024-519316-13-00, protocol PT00114-001A, at one German site, ran from August 1 to September 24, 2025 and is marked Ended with no results posted. Both parts were conducted outside the United States and not under a US investigational new drug application, and no ClinicalTrials.gov record or Australian registry entry exists. On August 20, 2026 Protagenic reported written responses to a Type B pre-IND meeting request: by its account the FDA identified no clinical hold issues, raised no objection to the planned three-part phase 1 or its dose escalation, and found no deficiency that would preclude an IND. The company plans to file that IND before the end of 2026 for generalized anxiety disorder, with a first patient dosed in the first half of 2027, and states that PT00114 is not approved by any regulatory authority and that its safety and efficacy have not been established. Its earlier filings refer to re-submitting an IND, without naming a date for any earlier submission.
You can compare this against the whole library, or read how to check a seller.
What else is like PT00114?
Others in Brain, mood and sleep, side by side.If you're weighing PT00114, it's worth reading Semax, Selank, and N-Acetyl Semax Amidate in the same class.
An injected peptide derived from TCAP-1, the tail end of the brain protein teneurin-1, aimed at anxiety through latrophilin receptors rather than the stress receptor other drugs block. Phase 1 is finished, and every result so far comes from company press releases.
- Dose
- 125 to 1,000 mcg per dose (phase 1 single-dose part)
- How often
- Once in the single-dose part
A peptide used for sharper focus, memory, and mental clarity.
- Dose
- 0.2 up to 0.6 mg per day
- How often
- 1-2x daily
A peptide that eases anxiety while keeping you clear-headed.
- Dose
- 0.25 up to 0.5 mg per day
- How often
- 1-2x daily
A longer-lasting version of Semax for focus and memory.
- Dose
- 0.2 up to 0.4 mg per day
- How often
- 1-2x daily
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- How to Read a Peptide COA
What the purity number does and does not tell you, and how to spot an edited report.
- How to Vet a Peptide Vendor
Independent COAs, HPLC purity, and the red flags that mean walk away.
Sources
- Protagenic Form 10-K, year ended March 31, 2026(2026)Describes PT00114 as a 41-residue peptide synthetic TCAP-1, an L-isomer and a naturally modified peptide; latrophilin-1 and latrophilin-3 mechanism without CRF-receptor blockade; University of Toronto license terms; patent table; first human dosing September 26, 2023; OTC market listing after delisting from Nasdaq.
- Protagenic Form 10-Q, quarter ended June 30, 2026(2026)Cash $565,985 at June 30, 2026 and $1,509,178 at March 31, 2026; stockholders' equity $1,723,392; research spending $109,925 against $394,112 a year earlier; substantial doubt about continuing as a going concern; the Phytanix transaction unwound February 17, 2026.
- Protagenic Form 8-K exhibit 99.1, August 20, 2026(2026)Type B pre-IND written responses with no clinical hold issues and no objection to a planned three-part phase 1; target indication generalized anxiety disorder; IND before the end of 2026 and first patient dosed in the first half of 2027; both completed parts were run outside the US, not under an IND, in healthy volunteers.
- Protagenic Form 8-K exhibit 99.1, May 22, 2024(2024)Single-dose part: 30 subjects in 5 cohorts, doses up to 1,000 micrograms, zero clinically relevant adverse events; the repeat-dose part was to begin later in 2024.
- Protagenic Form 8-K, filed August 22, 2025(2025)Nasdaq notice of August 20, 2025 for a late quarterly report; auditor changed from MaloneBailey to Green Growth CPAs, the earlier audit report carrying a going-concern paragraph; all repeat-dose first injections complete, with phase 2 then planned for the first quarter of 2026.
- Protagenic Form 10-K, filed March 31, 2025(2025)Describes a phase 1/2a design including patients with treatment-resistant depression, PTSD or generalized anxiety disorder and up to 28 days of exposure; Nasdaq appeal panel January 30, 2025 and a compliance deadline of April 28, 2025; Charles River and Porsolt named as preclinical contract laboratories; IND re-submission language.
- EU clinical trial record 2024-519316-13-00 (CTIS data via ctis.eu)(2025)The only registry record that exists: protocol PT00114-001A, randomized, placebo-controlled and double-blind in healthy volunteers, single site Nuvisan GmbH in Neu-Ulm, Germany, 24 planned, start August 1, 2025, end September 24, 2025, status Ended, no results posted. Its condition fields name anxiety disorder, mood disorders and post-traumatic stress disorder inconsistently.
- Protagenic press release, December 9, 2025(2025)Repeat-dose topline: well tolerated across all dose ranges, expected injection-site reactions, no serious adverse events, all cohorts completed; no enrollment, dose level or pharmacokinetic figure given; pharmacokinetic modeling still being finalized; the executive chairman's remark that several participants reported an improved sense of well-being, a remark he called anecdotal at this stage.
- Protagenic press release, March 27, 2024(2024)Cohorts 1 to 3 of 5 dosed at 125, 250 and 500 micrograms by subcutaneous injection; no adverse reactions in the week after the 500 microgram cohort; contract research organization Axiom Real-Time Metrics; principal investigator Maurizio Fava.
- Protagenic press release, February 13, 2024(2024)Cohort 1 at 125 micrograms, described as a 41-amino-acid synthetic peptide; zero reported adverse reactions over a 30-day observation period; cortisol used as a biomarker of initial response; the study described as including patients.
- US 11,426,444 B2, PTSD use patent (Google Patents)(2022)Human TCAP-1 as SEQ ID NO: 2, QQLLSTGRVQGYDGYFVLSVEQYLELSDSANNIHFMRQSEI, 41 residues with an amidated end and the N-terminal glutamine optionally present as pyroglutamate; no D-amino acids; inventors include the academic originator and three Protagenic officers; rat and mouse doses of 10 to 250 nanomoles per kilogram given under the skin.
- UniProt Q9UKZ4, human teneurin-1(2026)Teneurin-1 is 2,725 residues and ends with the patent's 41-mer followed by a GRR amidation signal, the motif an amidated C-terminal peptide is cut from.
- FDA GSRS substance search for PT00114(2026)No substance record. There is no UNII, no CAS number, no molecular formula and no proposed international nonproprietary name for PT00114, and a search for teneurin returns nothing either.
- Protagenic corporate website(2026)Calls PT00114 a first-in-class synthetic analog of TCAP, says phase 1 is complete, and links no scientific publications; reports an attenuated chronic stress response in a rodent model, and the move from OTC Pink to OTCQB on March 10, 2026.
Beyond these, 44 records are indexed. Browse the records